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

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ARIPIPRAZOLE USP

ASCORBIC ACID USP

ATORVASTATIN CALCIUM USP

Aceclofenac

Atorvastatin calcium trihydrate

CARBAMAZEPINE USP

CELECOXIB USP

CHLORTHALIDONE USP

CLOTRIMAZOLE USP

DICLOFENAC

DICLOFENAC DIETHYLAMINE

DICLOFENAC EPOLAMINE

DICLOFENAC POTASSIUM USP

DICLOFENAC SODIUM

DICLOFENAC SODIUM USP

Diclofenac Diethylamine (BP)

Dihydralazine sulfate, hydrated

HYDROCHLOROTHIAZIDE USP

Hydrated Dihydralazine Sulphate (BP/EP)

LEVETIRACETAM

LEVETIRACETAM USP [ROUTE CODE - LVS]

LINEZOLID [FORM-1]

LINEZOLID [FORM-II]

OLMESARTAN MEDOXOMIL USP

OXCARBAZEPINE USP

ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE FORM-II

SILDENAFIL CITRATE USP

SOLIFENACIN SUCCINATE

Sertraline HCL (IH)

Sodium Ascorbate (USP/BP)

TADALAFIL USP

TELMISARTAN USP

VENLAFAXINE HYDROCHLORIDE USP

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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218MF10010

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WC-0077

WC-0134

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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
2016-02-26
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
Aceclofenac
Issue/Submission Date
2016-02-26
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WITHDRAWN BY HOLDER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
Aceclofenac
Issue/Submission Date
2009-10-14
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0134
Status
Valid - 2019-07-02
Filing Details
Aceclofenac (BP/EP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0134
Status
WITHDRAWN BY HOLDER
 
Valid - 2019-07-02
Filing Details
Aceclofenac
Aceclofenac (BP/EP)
Issue/Submission Date
2009-10-14
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ARIPIPRAZOLE USP
Issue/Submission Date
2015-03-24
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ARIPIPRAZOLE USP
Issue/Submission Date
2015-03-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ASCORBIC ACID USP
Issue/Submission Date
2012-11-05
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-0077
Status
Valid - 2019-07-02
Filing Details
Ascorbic Acid (BP/USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ASCORBIC ACID USP
Ascorbic Acid (BP/USP)
Issue/Submission Date
2012-11-05
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
Atorvastatin calcium trihydrate
Issue/Submission Date
2016-06-03
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
Atorvastatin calcium trihydrate
Issue/Submission Date
2016-06-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATORVASTATIN CALCIUM USP
Issue/Submission Date
2011-11-04
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-0077
Status
Valid - 2019-07-02
Filing Details
Atorvastatin Calcium (USP/EP/IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ATORVASTATIN CALCIUM USP
Atorvastatin Calcium (USP/EP/IH)
Issue/Submission Date
2011-11-04
2016-07-12
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
2009-10-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carbamazepine
Issue/Submission Date
2016-11-17
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0077
Status
Valid - 2019-07-02
Filing Details
Carbamazepine (BP/USP/EP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CARBAMAZEPINE USP
Carbamazepine
Carbamazepine (BP/USP/EP)
Issue/Submission Date
2009-10-14
2016-11-17
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CELECOXIB USP
Issue/Submission Date
2012-01-03
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Celecoxib
Issue/Submission Date
2019-03-22
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0077
Status
Valid - 2019-07-02
Filing Details
Celecoxib (IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CELECOXIB USP
Celecoxib
Celecoxib (IH)
Issue/Submission Date
2012-01-03
2019-03-22
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CHLORTHALIDONE USP
Issue/Submission Date
2012-11-29
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CHLORTHALIDONE USP
Issue/Submission Date
2012-11-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CHLORTHALIDONE USP
Issue/Submission Date
2016-05-24
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CHLORTHALIDONE USP
Issue/Submission Date
2016-05-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOTRIMAZOLE USP
Issue/Submission Date
2012-10-12
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Clotrimazole
Issue/Submission Date
2013-09-19
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0134
Status
Valid - 2019-07-02
Filing Details
Clotrimazole (BP/EP/USP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0134
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CLOTRIMAZOLE USP
Clotrimazole
Clotrimazole (BP/EP/USP)
Issue/Submission Date
2012-10-12
2013-09-19
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICLOFENAC DIETHYLAMINE
Issue/Submission Date
2010-03-21
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-0134
Status
Valid - 2019-07-02
Filing Details
Diclofenac Free Acid
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0134
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
DICLOFENAC DIETHYLAMINE
Diclofenac Free Acid
Issue/Submission Date
2010-03-21
2016-06-23
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-0134
Status
Valid - 2019-07-02
Filing Details
Diclofenac Diethylamine (BP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0134
Status
 
Valid - 2019-07-02
Filing Details
Diclofenac Diethylamine (BP)
Issue/Submission Date
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICLOFENAC EPOLAMINE
Issue/Submission Date
2011-09-16
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
DICLOFENAC EPOLAMINE
Issue/Submission Date
2011-09-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DICLOFENAC POTASSIUM USP
Issue/Submission Date
2009-08-12
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Diclofenac potassium
Issue/Submission Date
2014-08-06
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0134
Status
Valid - 2019-07-02
Filing Details
Diclofenac Potassium (BP/EP/USP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0134
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
DICLOFENAC POTASSIUM USP
Diclofenac potassium
Diclofenac Potassium (BP/EP/USP)
Issue/Submission Date
2009-08-12
2014-08-06
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICLOFENAC SODIUM
Issue/Submission Date
1995-09-26
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Diclofenac sodium
Issue/Submission Date
2014-08-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
"Japan-station" diclofenac sodium (...
Issue/Submission Date
2006-01-27
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0134
Status
Valid - 2019-07-02
Filing Details
Diclofenac Sodium (BP/EP/USP)
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0134
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
DICLOFENAC SODIUM
Diclofenac sodium
"Japan-station" diclofenac sodium (...
Diclofenac Sodium (BP/EP/USP)
Issue/Submission Date
1995-09-26
2014-08-01
2006-01-27
2016-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DICLOFENAC SODIUM USP
Issue/Submission Date
2007-09-13
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 - Complete
 
Filing Details
DICLOFENAC SODIUM USP
Issue/Submission Date
2007-09-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DICLOFENAC
Issue/Submission Date
2014-04-18
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 - Complete
 
Filing Details
DICLOFENAC
Issue/Submission Date
2014-04-18
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
Dihydralazine sulfate, hydrated
Issue/Submission Date
2016-07-27
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
Dihydralazine sulfate, hydrated
Issue/Submission Date
2016-07-27
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-0134
Status
Valid - 2019-07-02
Filing Details
Hydrated Dihydralazine Sulphate (BP...
Issue/Submission Date
2016-06-23
Supporting Info
Application Number
Indian CDSCO WC-0134
Status
 
Valid - 2019-07-02
Filing Details
Hydrated Dihydralazine Sulphate (BP...
Issue/Submission Date
2016-06-23
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
2012-03-13
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Hydrochlorothiazide
Issue/Submission Date
2018-06-01
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 - Complete
VALID
 
Filing Details
HYDROCHLOROTHIAZIDE USP
Hydrochlorothiazide
Issue/Submission Date
2012-03-13
2018-06-01
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
2010-03-02
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Levetiracetam
Issue/Submission Date
2018-09-06
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0077
Status
Valid - 2019-07-02
Filing Details
Levetiracetam (EP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
LEVETIRACETAM
Levetiracetam
Levetiracetam (EP)
Issue/Submission Date
2010-03-02
2018-09-06
2016-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LEVETIRACETAM USP [ROUTE CODE - LVS...
Issue/Submission Date
2012-02-08
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
LEVETIRACETAM USP [ROUTE CODE - LVS...
Issue/Submission Date
2012-02-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LINEZOLID [FORM-1]
Issue/Submission Date
2013-09-13
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
LINEZOLID [FORM-1]
Issue/Submission Date
2013-09-13
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
LINEZOLID [FORM-II]
Issue/Submission Date
2013-11-12
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
LINEZOLID [FORM-II]
Issue/Submission Date
2013-11-12
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
OLMESARTAN MEDOXOMIL USP
Issue/Submission Date
2013-05-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Olmesartan medoxomil
Issue/Submission Date
2017-08-17
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 - Complete
VALID
 
Filing Details
OLMESARTAN MEDOXOMIL USP
Olmesartan medoxomil
Issue/Submission Date
2013-05-21
2017-08-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
OXCARBAZEPINE USP
Issue/Submission Date
2009-10-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Oxcarbazepine
Issue/Submission Date
2019-01-03
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0077
Status
Valid - 2019-07-02
Filing Details
Oxcarbazepine (USP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
OXCARBAZEPINE USP
Oxcarbazepine
Oxcarbazepine (USP)
Issue/Submission Date
2009-10-20
2019-01-03
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
ROSUVASTATIN CALCIUM
Issue/Submission Date
2014-10-07
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
ROSUVASTATIN CALCIUM
Issue/Submission Date
2014-10-07
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-0077
Status
Valid - 2019-07-02
Filing Details
Sertraline HCL (IH)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
 
Valid - 2019-07-02
Filing Details
Sertraline HCL (IH)
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
SILDENAFIL CITRATE FORM-II
Issue/Submission Date
2011-11-02
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Sildenafil citrate
Issue/Submission Date
2018-07-11
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0077
Status
Valid - 2019-07-02
Filing Details
Sildenafil Citrate (IH
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
SILDENAFIL CITRATE FORM-II
Sildenafil citrate
Sildenafil Citrate (IH
Issue/Submission Date
2011-11-02
2018-07-11
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
SILDENAFIL CITRATE USP
Issue/Submission Date
2011-11-02
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 - Complete
 
Filing Details
SILDENAFIL CITRATE USP
Issue/Submission Date
2011-11-02
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-0077
Status
Valid - 2019-07-02
Filing Details
Sodium Ascorbate (USP/BP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
 
Valid - 2019-07-02
Filing Details
Sodium Ascorbate (USP/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
SOLIFENACIN SUCCINATE
Issue/Submission Date
2017-08-03
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Solifenacin succinate
Issue/Submission Date
2018-08-01
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 - Complete
VALID
 
Filing Details
SOLIFENACIN SUCCINATE
Solifenacin succinate
Issue/Submission Date
2017-08-03
2018-08-01
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
TADALAFIL USP
Issue/Submission Date
2016-06-10
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Tadalafil
Issue/Submission Date
2018-03-02
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 - Complete
VALID
 
Filing Details
TADALAFIL USP
Tadalafil
Issue/Submission Date
2016-06-10
2018-03-02
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
TELMISARTAN USP
Issue/Submission Date
2012-10-17
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TELMISARTAN USP
Issue/Submission Date
2012-10-17
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
VENLAFAXINE HYDROCHLORIDE USP
Issue/Submission Date
2008-03-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Venlafaxine hydrochloride
Issue/Submission Date
2014-10-21
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0077
Status
Valid - 2019-07-02
Filing Details
Venlafaxine HCL (EP)
Issue/Submission Date
2016-07-12
Supporting Info
Application Number
Indian CDSCO WC-0077
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
VENLAFAXINE HYDROCHLORIDE USP
Venlafaxine hydrochloride
Venlafaxine HCL (EP)
Issue/Submission Date
2008-03-14
2014-10-21
2016-07-12
Supporting Info

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