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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Aarti Industries Ltd

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ADAPALENE

AZATHIOPRINE USP

Acamprosate Calcium BP/Ph.Eur

Aceclofenac

Aceclofenac (BP/EP)

Azathioprine

BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE POLYMORPH B

BICALUTAMIDE

BUDESONIDE USP

BUPROPION HYDROCHLORIDE

CAPECITABINE

CELECOXIB

CICLESONIDE

CIPROFLOXACIN HYDROCHLORIDE

Caffeine Anhydrous (IP/PH.Eur/BP/USP)

Caffeine Anhydrous IP/BP/EP/USP

Celecoxib (USP/EP/BP)

Ciprofloxacin Hydrochloride (BP/EP/USP)

Clopidogrel Bisulphate USP

Clopidogrel Hydrogen sulphate (BP/EP)

Cyclophosphamide (Ph.Eur./BP/USP)

DESONIDE

DICLOFENAC EPOLAMINE

DIFLUNISAL

Diclofenac Diethyl Ammonium (BP)

Diclofenac Potassium (BP/EP/USP)

Diclofenac sodium

FLUTICASONE PROPIONATE USP

Formoterol fumarate dihydrate

HYDROXYZINE HYDROCHLORIDE

IFOSFAMIDE

IPRATROPIUM BROMIDE

LEVALBUTEROL HCL

LORATADINE

LOTEPREDNOL ETABONATE

Lacidipine (BP)

Levofloxacin (USP)

MERCAPTOPURINE

MESNA

METFORMIN HYDROCHLORIDE USP

METOPROLOL SUCCINATE

MOMETASONE FUROATE

MOMETASONE FUROATE MONOHYDRATE

MOMETASONE FUROATE USP (ALTERNATE PROCESS)

Metformin Hydrochloride

Metronidazole

Metronidazole Benzoate (EP/BP/USP)

NIACIN

NIMESULIDE

Ofloxacin (IP/BP/USP/EP)

PIOGLITAZONE HYDROCHLORIDE

Perindopril tert-butylamine

QUETIAPINE FUMARATE USP

QUINAPRIL HYDROCHLORIDE USP

Quetiapine Fumarate(IH)

RALOXIFENE HYDROCHLORIDE USP

RAMIPRIL USP (GRADE A)

RAMIPRIL USP, GRADE II

RANOLAZINE

RIVASTIGMINE HYDROGEN TARTRATE

ROFECOXIB

Ranitidine hydrochloride (Form II)

S (-) RIVASTIGMINE BASE

SALMETEROL XINAFOATE

TERBINAFINE HYDROCHLORIDE

TERT-BUTYL(4-(2-CHLORO-5-IODOBENZYL)PHENOXY)DIMETHYLSILANE

TICLOPIDINE HYDROCHLORIDE

Ticlopidine HCI (BP/EP)

Tinidazole (EP)

Tolnaftate

Tolnaftate (EP/BP/USP)

VENLAFAXINE HYDROCHLORIDE POLYMORPH B

VENLAFAXINE HYDROCLORIDE

ZOLPIDEM TARTRATE

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY HOLDER

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221MF10180

224MF10159

227MF10240

228MF10126

228MF10169

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WC-0099

WC-0219

WC-0355

WC-0376

WC-0406

WC-250

WC-251

WC-252

WC-253

WC-295

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-253
Status
Valid - 2019-07-02
Filing Details
Acamprosate Calcium BP/Ph.Eur
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-253
Status
 
Valid - 2019-07-02
Filing Details
Acamprosate Calcium BP/Ph.Eur
Issue/Submission Date
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-253
Status
Valid - 2019-07-02
Filing Details
Aceclofenac (BP/EP)
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-253
Status
 
Valid - 2019-07-02
Filing Details
Aceclofenac (BP/EP)
Issue/Submission Date
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Aceclofenac
Issue/Submission Date
2015-06-25
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-251
Status
Valid - 2019-07-02
Filing Details
Aceclofenac (BP/EP)
Issue/Submission Date
2016-07-13
Supporting Info
Application Number
Indian CDSCO WC-251
Status
VALID
 
Valid - 2019-07-02
Filing Details
Aceclofenac
Aceclofenac (BP/EP)
Issue/Submission Date
2015-06-25
2016-07-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ADAPALENE
Issue/Submission Date
2009-04-08
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Adapalene at 71, UDYOG KSHETRA, ULN...
Issue/Submission Date
2016-07-13
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Adapalene (Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
ADAPALENE
Adapalene at 71, UDYOG KSHETRA, ULN...
Adapalene (Ph.Eur.)
Issue/Submission Date
2009-04-08
2016-07-13
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Azathioprine
Issue/Submission Date
2015-12-22
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Azathioprine
Issue/Submission Date
2015-12-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZATHIOPRINE USP
Issue/Submission Date
2009-08-11
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Azathioprine Process 2
Issue/Submission Date
2014-05-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Azathioprine (Ph.Eur./BP/USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
AZATHIOPRINE USP
Azathioprine Process 2
Azathioprine (Ph.Eur./BP/USP)
Issue/Submission Date
2009-08-11
2014-05-26
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BENAZEPRIL HYDROCHLORIDE
Issue/Submission Date
2006-12-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Benazepril hydrochloride
Issue/Submission Date
2018-05-16
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Benazepril Hydrochloride (USP/Ph. E...
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
BENAZEPRIL HYDROCHLORIDE
Benazepril hydrochloride
Benazepril Hydrochloride (USP/Ph. E...
Issue/Submission Date
2006-12-27
2018-05-16
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BENAZEPRIL HYDROCHLORIDE POLYMORPH ...
Issue/Submission Date
2009-06-09
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BENAZEPRIL HYDROCHLORIDE POLYMORPH ...
Issue/Submission Date
2009-06-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BICALUTAMIDE
Issue/Submission Date
2007-05-01
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Bicalutamide
Issue/Submission Date
2019-01-29
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
BICALUTAMIDE at 71, UDYOG KSHETRA, ...
Issue/Submission Date
2016-08-24
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Bicalutamide (USP/EP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
BICALUTAMIDE
Bicalutamide
BICALUTAMIDE at 71, UDYOG KSHETRA, ...
Bicalutamide (USP/EP)
Issue/Submission Date
2007-05-01
2019-01-29
2016-08-24
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUDESONIDE USP
Issue/Submission Date
2007-06-13
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Budesonide
Issue/Submission Date
2018-02-08
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Budesonide (BP/USP/Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
BUDESONIDE USP
Budesonide
Budesonide (BP/USP/Ph.Eur.)
Issue/Submission Date
2007-06-13
2018-02-08
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUPROPION HYDROCHLORIDE
Issue/Submission Date
2013-06-17
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Bupropion Hydrochloride (USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (USP)
Issue/Submission Date
2013-06-17
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-295
Status
Expired - 2017-09-18
Filing Details
Caffeine Anhydrous IP/BP/EP/USP
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-295
Status
 
Expired - 2017-09-18
Filing Details
Caffeine Anhydrous IP/BP/EP/USP
Issue/Submission Date
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0376
Status
Valid - 2019-07-01
Filing Details
Caffeine Anhydrous (IP/PH.Eur/BP/US...
Issue/Submission Date
2016-07-01
Supporting Info
Application Number
Indian CDSCO WC-0376
Status
 
Valid - 2019-07-01
Filing Details
Caffeine Anhydrous (IP/PH.Eur/BP/US...
Issue/Submission Date
2016-07-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CAPECITABINE
Issue/Submission Date
2009-07-17
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Capecitabine (USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
CAPECITABINE
Capecitabine (USP)
Issue/Submission Date
2009-07-17
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-253
Status
Valid - 2019-07-02
Filing Details
Celecoxib (USP/EP/BP)
Issue/Submission Date
2016-10-28
Supporting Info
Application Number
Indian CDSCO WC-253
Status
 
Valid - 2019-07-02
Filing Details
Celecoxib (USP/EP/BP)
Issue/Submission Date
2016-10-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CELECOXIB
Issue/Submission Date
2009-10-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Celecoxib
Issue/Submission Date
2018-05-23
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0219
Status
Valid - 2019-07-02
Filing Details
Celecoxib (EP)
Issue/Submission Date
2016-08-05
Supporting Info
Application Number
Indian CDSCO WC-0219
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CELECOXIB
Celecoxib
Celecoxib (EP)
Issue/Submission Date
2009-10-09
2018-05-23
2016-08-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CICLESONIDE
Issue/Submission Date
2010-03-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ciclesonide
Issue/Submission Date
2018-05-25
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Ciclesonide(IH/EP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CICLESONIDE
Ciclesonide
Ciclesonide(IH/EP)
Issue/Submission Date
2010-03-23
2018-05-25
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-250
Status
Valid - 2019-07-02
Filing Details
Ciprofloxacin Hydrochloride (BP/EP/...
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-250
Status
 
Valid - 2019-07-02
Filing Details
Ciprofloxacin Hydrochloride (BP/EP/...
Issue/Submission Date
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CIPROFLOXACIN HYDROCHLORIDE
Issue/Submission Date
2006-07-17
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ciprofloxacin Hydrochloride
Issue/Submission Date
2015-11-25
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0219
Status
Valid - 2019-07-02
Filing Details
Ciprofloxacin Hydrochloride (EP)
Issue/Submission Date
2016-08-05
Supporting Info
Application Number
Indian CDSCO WC-0219
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride
Ciprofloxacin Hydrochloride (EP)
Issue/Submission Date
2006-07-17
2015-11-25
2016-08-05
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-250
Status
Valid - 2019-07-02
Filing Details
Clopidogrel Bisulphate USP
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-250
Status
 
Valid - 2019-07-02
Filing Details
Clopidogrel Bisulphate USP
Issue/Submission Date
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-250
Status
Valid - 2019-07-02
Filing Details
Clopidogrel Hydrogen sulphate (BP/E...
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-250
Status
 
Valid - 2019-07-02
Filing Details
Clopidogrel Hydrogen sulphate (BP/E...
Issue/Submission Date
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Cyclophosphamide (Ph.Eur./BP/USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
 
Valid - 2019-07-02
Filing Details
Cyclophosphamide (Ph.Eur./BP/USP)
Issue/Submission Date
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DESONIDE
Issue/Submission Date
2009-07-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Desonide (IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
DESONIDE
Desonide (IH)
Issue/Submission Date
2009-07-20
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-250
Status
Valid - 2019-07-02
Filing Details
Diclofenac Diethyl Ammonium (BP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-250
Status
 
Valid - 2019-07-02
Filing Details
Diclofenac Diethyl Ammonium (BP)
Issue/Submission Date
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICLOFENAC EPOLAMINE
Issue/Submission Date
2012-04-03
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0219
Status
Valid - 2019-07-02
Filing Details
Diclofenac Epolamine (IH)
Issue/Submission Date
2016-01-06
Supporting Info
Application Number
Indian CDSCO WC-0219
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
DICLOFENAC EPOLAMINE
Diclofenac Epolamine (IH)
Issue/Submission Date
2012-04-03
2016-01-06
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-250
Status
Valid - 2019-07-02
Filing Details
Diclofenac Potassium (BP/EP/USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-250
Status
 
Valid - 2019-07-02
Filing Details
Diclofenac Potassium (BP/EP/USP)
Issue/Submission Date
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Diclofenac sodium
Issue/Submission Date
2008-12-05
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Diclofenac Sodium JP at Mahendra In...
Issue/Submission Date
2012-08-16
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-250
Status
Valid - 2019-07-02
Filing Details
Diclofenac Sodium (BP/EP/USP/JP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-250
Status
WITHDRAWN BY HOLDER
 
Valid - 2019-07-02
Filing Details
Diclofenac sodium
Diclofenac Sodium JP at Mahendra In...
Diclofenac Sodium (BP/EP/USP/JP)
Issue/Submission Date
2008-12-05
2012-08-16
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIFLUNISAL
Issue/Submission Date
2011-03-15
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DIFLUNISAL
Issue/Submission Date
2011-03-15
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FLUTICASONE PROPIONATE USP
Issue/Submission Date
2009-07-22
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Fluticasone propionate
Issue/Submission Date
2016-10-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Fluticasone Propionate (Ph.Eur./BP/...
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
FLUTICASONE PROPIONATE USP
Fluticasone propionate
Fluticasone Propionate (Ph.Eur./BP/...
Issue/Submission Date
2009-07-22
2016-10-26
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Formoterol fumarate dihydrate
Issue/Submission Date
2017-02-07
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Formoterol fumarate dihydrate
Issue/Submission Date
2017-02-07
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
HYDROXYZINE HYDROCHLORIDE
Issue/Submission Date
2008-10-06
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
HYDROXYZINE HYDROCHLORIDE
Issue/Submission Date
2008-10-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IFOSFAMIDE
Issue/Submission Date
2009-07-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Ifosfamide (BP/USP/Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
IFOSFAMIDE
Ifosfamide (BP/USP/Ph.Eur.)
Issue/Submission Date
2009-07-20
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IPRATROPIUM BROMIDE
Issue/Submission Date
2007-12-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ipratropium bromide
Issue/Submission Date
2017-02-14
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Ipratropium Bromide (BP/ Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
IPRATROPIUM BROMIDE
Ipratropium bromide
Ipratropium Bromide (BP/ Ph.Eur.)
Issue/Submission Date
2007-12-15
2017-02-14
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Lacidipine (BP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
 
Valid - 2019-07-02
Filing Details
Lacidipine (BP)
Issue/Submission Date
2016-07-12
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LEVALBUTEROL HCL
Issue/Submission Date
2007-05-23
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Levalbuterol Hydrochloride (USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
LEVALBUTEROL HCL
Levalbuterol Hydrochloride (USP)
Issue/Submission Date
2007-05-23
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0406
Status
Valid - 2021-07-07
Filing Details
Levofloxacin (USP)
Issue/Submission Date
2018-07-07
Supporting Info
Application Number
Indian CDSCO WC-0406
Status
 
Valid - 2021-07-07
Filing Details
Levofloxacin (USP)
Issue/Submission Date
2018-07-07
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LORATADINE
Issue/Submission Date
2007-04-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LORATADINE
Issue/Submission Date
2007-04-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LOTEPREDNOL ETABONATE
Issue/Submission Date
2012-07-26
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Loteprednol Etabonate (IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
LOTEPREDNOL ETABONATE
Loteprednol Etabonate (IH)
Issue/Submission Date
2012-07-26
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MERCAPTOPURINE
Issue/Submission Date
2009-07-21
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Mercaptopurine (EP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
MERCAPTOPURINE
Mercaptopurine (EP)
Issue/Submission Date
2009-07-21
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MESNA
Issue/Submission Date
2009-03-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mesna
Issue/Submission Date
2015-06-05
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Mesna (BP/USP/Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
MESNA
Mesna
Mesna (BP/USP/Ph.Eur.)
Issue/Submission Date
2009-03-23
2015-06-05
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
METFORMIN HYDROCHLORIDE USP
Issue/Submission Date
2008-02-01
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Metformin Hydrochloride
Issue/Submission Date
2018-12-12
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-250
Status
Valid - 2019-07-02
Filing Details
Metformin Hydrochloride (BP/EP/USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-250
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
METFORMIN HYDROCHLORIDE USP
Metformin Hydrochloride
Metformin Hydrochloride (BP/EP/USP)
Issue/Submission Date
2008-02-01
2018-12-12
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Metformin Hydrochloride
Issue/Submission Date
2009-04-09
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0355
Status
Expired - 2019-02-18
Filing Details
Metformin Hydrochloride EP/BP/USP
Issue/Submission Date
2016-02-18
Supporting Info
Application Number
Indian CDSCO WC-0355
Status
WITHDRAWN BY HOLDER
 
Expired - 2019-02-18
Filing Details
Metformin Hydrochloride
Metformin Hydrochloride EP/BP/USP
Issue/Submission Date
2009-04-09
2016-02-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
METOPROLOL SUCCINATE
Issue/Submission Date
2006-06-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0219
Status
Valid - 2019-07-02
Filing Details
Metoprolol Succinate (EP/BP)
Issue/Submission Date
2017-01-06
Supporting Info
Application Number
Indian CDSCO WC-0219
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
METOPROLOL SUCCINATE
Metoprolol Succinate (EP/BP)
Issue/Submission Date
2006-06-01
2017-01-06
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Metronidazole
Issue/Submission Date
2006-10-23
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
WITHDRAWN BY HOLDER
 
Filing Details
Metronidazole
Issue/Submission Date
2006-10-23
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-252
Status
Valid - 2019-07-02
Filing Details
Metronidazole Benzoate (EP/BP/USP)
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-252
Status
 
Valid - 2019-07-02
Filing Details
Metronidazole Benzoate (EP/BP/USP)
Issue/Submission Date
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MOMETASONE FUROATE
Issue/Submission Date
2008-02-12
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mometasone furoate
Issue/Submission Date
2018-10-05
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Mometasone Furoate (BP/USP/Ph.Eur.)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
MOMETASONE FUROATE
Mometasone furoate
Mometasone Furoate (BP/USP/Ph.Eur.)
Issue/Submission Date
2008-02-12
2018-10-05
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MOMETASONE FUROATE MONOHYDRATE
Issue/Submission Date
2010-07-14
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0099
Status
Valid - 2019-07-02
Filing Details
Mometasone Furoate Monohydrate( IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0099
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
MOMETASONE FUROATE MONOHYDRATE
Mometasone Furoate Monohydrate( IH)
Issue/Submission Date
2010-07-14
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MOMETASONE FUROATE MONOHYDRATE
Issue/Submission Date
2014-04-11
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MOMETASONE FUROATE MONOHYDRATE
Issue/Submission Date
2014-04-11
Supporting Info