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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alp Pharm Beijing Co., Ltd

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ABIRATERONE ACETATE

ADAPALENE (DRUG SUBTANCE NON-STERILE)

ADEFOVIR DIPIVOXIL

ALOGLIPTIN BENZOATE

ALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE)

ALVIMOPAN DIHYDRATE

AMIFOSTINE

AMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE)

AMLODIPINE BESYLATE (NON-STERILE DRUG SUBSTANCE)

ARGATROBAN HYDRATE

ATORVASTATION CALCIUM (DRUG SUBSTANCE, NON-STERILE)

AZILSARTAN MEDOXOMIL

AZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE)

Amlodipine besilate

BACITRACIN

BACITRACIN ZINC

BECLOMETHASONE DIPROPIONATE

BENZOCAINE USP NON STERILE BULK DRUG SUBSTANCE

BESIFLOXACIN HYDROCHLORIDE

BIVALIRUDIN

BOSUTINIB

BRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE)

BROENAC SODIUM HYDRATE

CALCIPOTRIENE (CALCIPOTRIOL)

CALCIPOTRIENE HYDRATE

CALCITONON SALMON

CARISOPRODOL (DRUG SUBSTANCE, NON-STERILE)

CICLESONIDE

CIDOFOVIR DIHYDRATE

CILOSTAZOL DRUG SUBSTANCE NON STERILE

CILOSTAZOL USP

CILOSTAZOL USP (DRUG SUBSTANCE, NON-STERILE)

CISATRACURIUM BESYLATE

CLADRIBINE NON-STERILE BULK DRUG

CLEVIDIPINE BUTYRATE

CLOPIDOGREL BISULFATE FORM II

CYTARABINE USP NON-STERILE BULK DRUG

D-METHIONINE

D-PENICILLAMINE USP

DALTEPARIN SODIUM (DRUG SUBSTANCE, NON-STERILE)

DAPAGLIFLOZIN PROPANEDIOL

DASATINIB

DOXAZOSIN MESYLATE USP

DOXERCALCIFEROL

DRONEDARONE HYDROCHLORIDE

ELOCALCITOL

EMPAGLIFLOZIN

EPO (RECOMBINANT HUMAN ERYTHROPOIETIN)

EPTIFIBATIDE

ERGOCALCIFEROL USP

ESZOPICLONE

FEBUXOSTAT

FELODIPINE

GOSERELIN ACETATE

HYDROXYCHLOROQUINE SULFATE USP

IRINOTECAN HYDROCHLORIDE

ITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE)

LANREOTIDE ACETATE

LAPATINIB DITOSYLATE

LEUCOVORIN CALCIUM

LIRAGLUTIDE

LOTEPREDNOL ETABONATE

LURASIDONE HYDROCHLORIDE

LUTEIN (DRUG SUBSTANCE, NON-STERILE)

MEPROBAMATE (DRUG SUBSTANCE, NON-STERILE)

MESALAMINE

MOXIFLOXACIN HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE)

NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE)

NELARABINE

NEPAFENAC

OCTREOTIDE ACETATE

OLAPARIB

PALONOSETRON HYDROCHLORIDE

PARICALCITOL USP (NON-STERILE DRUG SUBSTANCE)

POLYMYXIN B SULFATE USP

POSACONAZOLE FOMR I

RIFABUTIN USP

RIZATRIPTAN BENZOATE

ROFLUMILAST

ROSMARINIC ACID (DRUG SUBSTANCE, NON-STERILE)

SERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE)

SILODOSIN

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CHARLOTTE, NC.

TAMSULOSIN HYDROCHLORIDE

TIGECYCLINE

TRANEXAMIC ACID

Tranexamic Acid

URSODEOXYCHOLIC ACID (DRUG SUBSTANCE NON-STERILE)

VARENICLINE TARTRATE

VERTEPORFIN

VINORELBINE TARTRATE

VORTIOXETINE HYDROBROMIDE

ZOLEDRONIC ACID

Zoledronic acid monohydrate

cetrorelix acetate

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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224MF10046

224MF10132

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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ABIRATERONE ACETATE
Issue/Submission Date
2014-06-24
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 - Unpaid
DMF Review - N/A
 
Filing Details
ABIRATERONE ACETATE
Issue/Submission Date
2014-06-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ADAPALENE (DRUG SUBTANCE NON-STERIL...
Issue/Submission Date
2010-01-30
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 - Unpaid
DMF Review - N/A
 
Filing Details
ADAPALENE (DRUG SUBTANCE NON-STERIL...
Issue/Submission Date
2010-01-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ADEFOVIR DIPIVOXIL
Issue/Submission Date
2010-10-21
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ADEFOVIR DIPIVOXIL
Issue/Submission Date
2010-10-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - Complete
Filing Details
ALOGLIPTIN BENZOATE
Issue/Submission Date
2014-05-19
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 - Unpaid
DMF Review - Complete
 
Filing Details
ALOGLIPTIN BENZOATE
Issue/Submission Date
2014-05-19
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ALPRAZOLAM USP (DRUG SUBSTANCE, NON...
Issue/Submission Date
2008-09-01
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ALPRAZOLAM USP (DRUG SUBSTANCE, NON...
Issue/Submission Date
2008-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ALVIMOPAN DIHYDRATE
Issue/Submission Date
2010-07-26
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ALVIMOPAN DIHYDRATE
Issue/Submission Date
2010-07-26
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ALVIMOPAN DIHYDRATE
Issue/Submission Date
2012-04-02
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ALVIMOPAN DIHYDRATE
Issue/Submission Date
2012-04-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
AMIFOSTINE
Issue/Submission Date
2009-05-26
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
AMIFOSTINE
Issue/Submission Date
2009-05-26
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
Amlodipine besilate
Issue/Submission Date
2016-08-02
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
VALID
 
Filing Details
Amlodipine besilate
Issue/Submission Date
2016-08-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
AMLODIPINE BESYLATE (NON-STERILE DR...
Issue/Submission Date
2008-01-16
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
AMLODIPINE BESYLATE (NON-STERILE DR...
Issue/Submission Date
2008-01-16
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
AMLODIPINE BESYLATE (DRUG SUBSTANCE...
Issue/Submission Date
2008-09-01
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
AMLODIPINE BESYLATE (DRUG SUBSTANCE...
Issue/Submission Date
2008-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ARGATROBAN HYDRATE
Issue/Submission Date
2012-02-20
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ARGATROBAN HYDRATE
Issue/Submission Date
2012-02-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ATORVASTATION CALCIUM (DRUG SUBSTAN...
Issue/Submission Date
2008-10-23
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ATORVASTATION CALCIUM (DRUG SUBSTAN...
Issue/Submission Date
2008-10-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
AZILSARTAN MEDOXOMIL
Issue/Submission Date
2015-09-24
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 - Unpaid
DMF Review - N/A
 
Filing Details
AZILSARTAN MEDOXOMIL
Issue/Submission Date
2015-09-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
AZTREONAM USP (NON-STERILE BULK DRU...
Issue/Submission Date
2010-07-06
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 - Unpaid
DMF Review - N/A
 
Filing Details
AZTREONAM USP (NON-STERILE BULK DRU...
Issue/Submission Date
2010-07-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BACITRACIN
Issue/Submission Date
2010-07-02
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 - Unpaid
DMF Review - N/A
 
Filing Details
BACITRACIN
Issue/Submission Date
2010-07-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BACITRACIN ZINC
Issue/Submission Date
2010-07-02
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
BACITRACIN ZINC
Issue/Submission Date
2010-07-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BECLOMETHASONE DIPROPIONATE
Issue/Submission Date
2009-07-31
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 - Unpaid
DMF Review - N/A
 
Filing Details
BECLOMETHASONE DIPROPIONATE
Issue/Submission Date
2009-07-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BENZOCAINE USP NON STERILE BULK DRU...
Issue/Submission Date
2009-11-16
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 - Unpaid
DMF Review - N/A
 
Filing Details
BENZOCAINE USP NON STERILE BULK DRU...
Issue/Submission Date
2009-11-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BESIFLOXACIN HYDROCHLORIDE
Issue/Submission Date
2018-03-08
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 - Unpaid
DMF Review - N/A
 
Filing Details
BESIFLOXACIN HYDROCHLORIDE
Issue/Submission Date
2018-03-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BIVALIRUDIN
Issue/Submission Date
2010-09-15
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 - Unpaid
DMF Review - N/A
 
Filing Details
BIVALIRUDIN
Issue/Submission Date
2010-09-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BOSUTINIB
Issue/Submission Date
2016-12-12
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 - Unpaid
DMF Review - N/A
 
Filing Details
BOSUTINIB
Issue/Submission Date
2016-12-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
BRINZOLAMIDE USP (DRUG SUBSTANCE, N...
Issue/Submission Date
2010-04-22
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 - Unpaid
DMF Review - N/A
 
Filing Details
BRINZOLAMIDE USP (DRUG SUBSTANCE, N...
Issue/Submission Date
2010-04-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - Complete
Filing Details
BROENAC SODIUM HYDRATE
Issue/Submission Date
2009-07-31
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 - Unpaid
DMF Review - Complete
 
Filing Details
BROENAC SODIUM HYDRATE
Issue/Submission Date
2009-07-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CALCIPOTRIENE (CALCIPOTRIOL)
Issue/Submission Date
2008-09-01
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CALCIPOTRIENE (CALCIPOTRIOL)
Issue/Submission Date
2008-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CALCIPOTRIENE HYDRATE
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 - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CALCIPOTRIENE HYDRATE
Issue/Submission Date
2013-09-06
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CALCITONON SALMON
Issue/Submission Date
2010-07-20
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CALCITONON SALMON
Issue/Submission Date
2010-07-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CARISOPRODOL (DRUG SUBSTANCE, NON-S...
Issue/Submission Date
2008-10-23
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CARISOPRODOL (DRUG SUBSTANCE, NON-S...
Issue/Submission Date
2008-10-23
Supporting Info
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USDMF

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CEP/COS

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Japanese DMF

Application Number
Status
 
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Issue/Submission Date
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Written Confirmation

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Status
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Issue/Submission Date
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Application Number
Status
 
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USDMF

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Status
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Issue/Submission Date
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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
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Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
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Written Confirmation

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CICLESONIDE
Issue/Submission Date
2010-09-10
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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
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Japanese DMF

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Status
 
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Issue/Submission Date
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Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CICLESONIDE
Issue/Submission Date
2010-09-10
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CIDOFOVIR DIHYDRATE
Issue/Submission Date
2010-01-08
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Issue/Submission Date
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Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CIDOFOVIR DIHYDRATE
Issue/Submission Date
2010-01-08
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CILOSTAZOL USP
Issue/Submission Date
2011-12-22
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CEP/COS

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Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CILOSTAZOL USP
Issue/Submission Date
2011-12-22
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CILOSTAZOL USP (DRUG SUBSTANCE, NON...
Issue/Submission Date
2009-01-16
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Cilostazol at No. 4 HUAZHONG ROAD, ...
Issue/Submission Date
2012-03-12
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CILOSTAZOL USP (DRUG SUBSTANCE, NON...
Cilostazol at No. 4 HUAZHONG ROAD, ...
Issue/Submission Date
2009-01-16
2012-03-12
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CILOSTAZOL DRUG SUBSTANCE NON STERI...
Issue/Submission Date
2008-12-25
Supporting Info
CEP/COS

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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 - Unpaid
DMF Review - N/A
 
Filing Details
CILOSTAZOL DRUG SUBSTANCE NON STERI...
Issue/Submission Date
2008-12-25
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CISATRACURIUM BESYLATE
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CISATRACURIUM BESYLATE
Issue/Submission Date
2010-07-14
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CLADRIBINE NON-STERILE BULK DRUG
Issue/Submission Date
2009-10-16
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CLADRIBINE NON-STERILE BULK DRUG
Issue/Submission Date
2009-10-16
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CLEVIDIPINE BUTYRATE
Issue/Submission Date
2016-08-10
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CLEVIDIPINE BUTYRATE
Issue/Submission Date
2016-08-10
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CLOPIDOGREL BISULFATE FORM II
Issue/Submission Date
2013-09-29
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 - Unpaid
DMF Review - N/A
 
Filing Details
CLOPIDOGREL BISULFATE FORM II
Issue/Submission Date
2013-09-29
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CYTARABINE USP NON-STERILE BULK DRU...
Issue/Submission Date
2010-01-12
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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CYTARABINE USP NON-STERILE BULK DRU...
Issue/Submission Date
2010-01-12
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
D-METHIONINE
Issue/Submission Date
2012-03-15
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 - Unpaid
DMF Review - N/A
 
Filing Details
D-METHIONINE
Issue/Submission Date
2012-03-15
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DALTEPARIN SODIUM (DRUG SUBSTANCE, ...
Issue/Submission Date
2008-09-01
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
DALTEPARIN SODIUM (DRUG SUBSTANCE, ...
Issue/Submission Date
2008-09-01
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DAPAGLIFLOZIN PROPANEDIOL
Issue/Submission Date
2015-06-27
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 - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
DAPAGLIFLOZIN PROPANEDIOL
Issue/Submission Date
2015-06-27
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DASATINIB
Issue/Submission Date
2015-09-09
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 - Unpaid
DMF Review - N/A
 
Filing Details
DASATINIB
Issue/Submission Date
2015-09-09
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DOXAZOSIN MESYLATE USP
Issue/Submission Date
2007-06-30
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 - Unpaid
DMF Review - N/A
 
Filing Details
DOXAZOSIN MESYLATE USP
Issue/Submission Date
2007-06-30
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DOXERCALCIFEROL
Issue/Submission Date
2011-03-04
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
DOXERCALCIFEROL
Issue/Submission Date
2011-03-04
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-10-30
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 - Unpaid
DMF Review - N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-10-30
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DRONEDARONE HYDROCHLORIDE
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 - Unpaid
DMF Review - N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2014-04-18
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ELOCALCITOL
Issue/Submission Date
2008-12-02
Supporting Info
CEP/COS

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

Application Number
Status