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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ctx Lifesciences Private Limited

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ACETAZOLAMIDE USP

ALENDRONATE SODIUM USP

AMIODARONE HYDROCHLORIDE USP

CARBAMAZEPINE USP

CARVEDILOL (ROUTE-II)

CHLOROTHIAZIDE USP

COLESEVELAM HYDROCHLORIDE

DEFERASIROX

DULOXETINE HYDROCHLORIDE USP

ESLICARBAZEPINE ACETATE

Felbinac

Hydrochlorothiazide USP

IRBESARTAN USP

LAMOTRIGINE USP

LEVETIRACETAM

MESALAMINE USP

METOPROLOL SUCCINATE USP

METOPROLOL TARTRATE USP

METOPROLOL TARTRATE USP (ROUTE-I)

Mesalazine BP

OLMESARTAN MEDOXOMIL

OXCARBAZEPINE (ROUTE-I)

OXYMETAZOLINE HYDROCHLORIDE USP

Ondansetron Hydrochloride Dihydrate USP/EP/BP

PREGABALIN

Rosuvastatin Calcium IH/IP

SEVELAMER CARBONATE

SEVELAMER HYDROCHLORIDE

TERAZOSIN HYDROCHLORIDE DIHYDRATE USP

XYLOMETAZOLINE HYDROCHLORIDE USP

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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223MF10173

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WC-0097

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ACETAZOLAMIDE USP
Issue/Submission Date
2009-07-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Acetazolamide
Issue/Submission Date
2018-05-18
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Acetazolamide(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
ACETAZOLAMIDE USP
Acetazolamide
Acetazolamide(Ph. Eur.)
Issue/Submission Date
2009-07-31
2018-05-18
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALENDRONATE SODIUM USP
Issue/Submission Date
2012-03-24
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
ALENDRONATE SODIUM USP
Issue/Submission Date
2012-03-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMIODARONE HYDROCHLORIDE USP
Issue/Submission Date
2012-04-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Amiodarone hydrochloride
Issue/Submission Date
2016-03-14
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Amiodarone Hydrochloride(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
AMIODARONE HYDROCHLORIDE USP
Amiodarone hydrochloride
Amiodarone Hydrochloride(Ph. Eur.)
Issue/Submission Date
2012-04-09
2016-03-14
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CARBAMAZEPINE USP
Issue/Submission Date
2010-09-17
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carbamazepine
Issue/Submission Date
2016-03-03
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Carbamazepine(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CARBAMAZEPINE USP
Carbamazepine
Carbamazepine(Ph. Eur.)
Issue/Submission Date
2010-09-17
2016-03-03
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CARVEDILOL (ROUTE-II)
Issue/Submission Date
2010-08-12
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carvedilol
Issue/Submission Date
2018-08-06
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Carvedilol USP/EP/BP
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CARVEDILOL (ROUTE-II)
Carvedilol
Carvedilol USP/EP/BP
Issue/Submission Date
2010-08-12
2018-08-06
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CHLOROTHIAZIDE USP
Issue/Submission Date
2009-07-23
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-0097
Status
Valid - 2019-07-02
Filing Details
Chlorothiazide EP/USP
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
CHLOROTHIAZIDE USP
Chlorothiazide EP/USP
Issue/Submission Date
2009-07-23
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
COLESEVELAM HYDROCHLORIDE
Issue/Submission Date
2013-09-27
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
COLESEVELAM HYDROCHLORIDE
Issue/Submission Date
2013-09-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEFERASIROX
Issue/Submission Date
2016-01-27
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-0097
Status
Valid - 2019-07-02
Filing Details
Deferasirox IH
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
DEFERASIROX
Deferasirox IH
Issue/Submission Date
2016-01-27
2017-02-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DULOXETINE HYDROCHLORIDE USP
Issue/Submission Date
2015-07-29
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-0097
Status
Valid - 2019-07-02
Filing Details
Duloxetine Hydrochloride EP/ USP
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
DULOXETINE HYDROCHLORIDE USP
Duloxetine Hydrochloride EP/ USP
Issue/Submission Date
2015-07-29
2017-02-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESLICARBAZEPINE ACETATE
Issue/Submission Date
2016-01-29
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-0097
Status
Valid - 2019-07-02
Filing Details
Eslicarbazepine Acetate IH
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
ESLICARBAZEPINE ACETATE
Eslicarbazepine Acetate IH
Issue/Submission Date
2016-01-29
2017-02-14
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
Felbinac at Block # 251-252, Sachin...
Issue/Submission Date
2011-12-22
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Felbinac at Block # 251-252, Sachin...
Issue/Submission Date
2011-12-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
Hydrochlorothiazide USP
Issue/Submission Date
2007-11-04
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Hydrochlorothiazide
Issue/Submission Date
2017-02-06
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Hydrochlorothiazide (Ph. Eur)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
Hydrochlorothiazide USP
Hydrochlorothiazide
Hydrochlorothiazide (Ph. Eur)
Issue/Submission Date
2007-11-04
2017-02-06
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
IRBESARTAN USP
Issue/Submission Date
2011-04-19
Supporting Info

CEP/COS

Application Number
Status
VALID
Filing Details
Irbesartan
Issue/Submission Date
2018-02-28
Supporting Info

Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

Written Confirmation

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Irbesartan(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info

Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
IRBESARTAN USP
Irbesartan
Irbesartan(Ph. Eur.)
Issue/Submission Date
2011-04-19
2018-02-28
2016-06-15
Supporting Info

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LAMOTRIGINE USP
Issue/Submission Date
2011-06-06
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Lamotrigine
Issue/Submission Date
2018-10-30
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Lamotrigine(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
LAMOTRIGINE USP
Lamotrigine
Lamotrigine(Ph. Eur.)
Issue/Submission Date
2011-06-06
2018-10-30
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LEVETIRACETAM
Issue/Submission Date
2013-09-06
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
LEVETIRACETAM
Issue/Submission Date
2013-09-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MESALAMINE USP
Issue/Submission Date
2015-02-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mesalazine
Issue/Submission Date
2016-06-29
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Mesalamine USP/EP
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
MESALAMINE USP
Mesalazine
Mesalamine USP/EP
Issue/Submission Date
2015-02-20
2016-06-29
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-0097
Status
Valid - 2019-07-02
Filing Details
Mesalazine BP
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
 
Valid - 2019-07-02
Filing Details
Mesalazine BP
Issue/Submission Date
2016-06-15
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
METOPROLOL SUCCINATE USP
Issue/Submission Date
2008-06-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Metoprolol succinate
Issue/Submission Date
2018-04-03
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Metoprolol Succinate(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
METOPROLOL SUCCINATE USP
Metoprolol succinate
Metoprolol Succinate(Ph. Eur.)
Issue/Submission Date
2008-06-14
2018-04-03
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
METOPROLOL TARTRATE USP
Issue/Submission Date
2008-02-01
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Metoprolol tartrate
Issue/Submission Date
2009-10-15
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Metoprolol Tartrate(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
WITHDRAWN BY HOLDER
 
Valid - 2019-07-02
Filing Details
METOPROLOL TARTRATE USP
Metoprolol tartrate
Metoprolol Tartrate(Ph. Eur.)
Issue/Submission Date
2008-02-01
2009-10-15
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
METOPROLOL TARTRATE USP (ROUTE-I)
Issue/Submission Date
2009-06-25
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Metoprolol tartrate Route I
Issue/Submission Date
2018-04-04
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
VALID
 
Filing Details
METOPROLOL TARTRATE USP (ROUTE-I)
Metoprolol tartrate Route I
Issue/Submission Date
2009-06-25
2018-04-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
OLMESARTAN MEDOXOMIL
Issue/Submission Date
2012-07-10
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-0097
Status
Valid - 2019-07-02
Filing Details
Olmesartan Medoxomil(Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
OLMESARTAN MEDOXOMIL
Olmesartan Medoxomil(Ph. Eur.)
Issue/Submission Date
2012-07-10
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-0097
Status
Valid - 2019-07-02
Filing Details
Ondansetron Hydrochloride Dihydrate...
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
 
Valid - 2019-07-02
Filing Details
Ondansetron Hydrochloride Dihydrate...
Issue/Submission Date
2016-06-15
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
OXCARBAZEPINE (ROUTE-I)
Issue/Submission Date
2009-11-30
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
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Oxcarbazepine (IH)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
OXCARBAZEPINE (ROUTE-I)
Oxcarbazepine (IH)
Issue/Submission Date
2009-11-30
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
OXYMETAZOLINE HYDROCHLORIDE USP
Issue/Submission Date
2008-12-10
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Oxymetazoline hydrochloride
Issue/Submission Date
2018-05-18
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Oxymetazoline HCI (Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
OXYMETAZOLINE HYDROCHLORIDE USP
Oxymetazoline hydrochloride
Oxymetazoline HCI (Ph. Eur.)
Issue/Submission Date
2008-12-10
2018-05-18
2016-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PREGABALIN
Issue/Submission Date
2012-07-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Pregabalin
Issue/Submission Date
2019-01-11
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Pregabalin (IH)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
PREGABALIN
Pregabalin
Pregabalin (IH)
Issue/Submission Date
2012-07-31
2019-01-11
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-0097
Status
Valid - 2019-07-02
Filing Details
Rosuvastatin Calcium IH/IP
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
 
Valid - 2019-07-02
Filing Details
Rosuvastatin Calcium IH/IP
Issue/Submission Date
2017-02-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
SEVELAMER CARBONATE
Issue/Submission Date
2014-05-28
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-0097
Status
Valid - 2019-07-02
Filing Details
Sevelamer Carbonate IH
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
SEVELAMER CARBONATE
Sevelamer Carbonate IH
Issue/Submission Date
2014-05-28
2016-06-15
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
SEVELAMER HYDROCHLORIDE
Issue/Submission Date
2013-09-27
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-0097
Status
Valid - 2019-07-02
Filing Details
Sevelamer Hydrochloride IH
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride IH
Issue/Submission Date
2013-09-27
2016-06-15
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
TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
Issue/Submission Date
2012-03-24
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-0097
Status
Valid - 2019-07-02
Filing Details
Terazosin Hydrochloride Dihydrate U...
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
Terazosin Hydrochloride Dihydrate U...
Issue/Submission Date
2012-03-24
2016-06-15
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
XYLOMETAZOLINE HYDROCHLORIDE USP
Issue/Submission Date
2008-09-19
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Xylometazoline hydrochloride
Issue/Submission Date
2017-09-18
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0097
Status
Valid - 2019-07-02
Filing Details
Xylometazoline HCI (Ph. Eur.)
Issue/Submission Date
2016-06-15
Supporting Info
Application Number
Indian CDSCO WC-0097
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
XYLOMETAZOLINE HYDROCHLORIDE USP
Xylometazoline hydrochloride
Xylometazoline HCI (Ph. Eur.)
Issue/Submission Date
2008-09-19
2017-09-18
2016-06-15
Supporting Info

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