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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by F.i.s. Fabbrica Italiana Sintetici Spa

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(R)-BAP L-MA

ACETYLCYSTEINE, USP

ALLOPURINOL

AMIODARONE HCL

APIXABAN

BENZYL HYDRAZINE MSA (FIS0181)

BRETYLIUM TOSYLATE, BULK FORM

Bromazepam

CALCIUM CHANNEL BLOCKER - RO 40-5967/001

CARBAMAZEPINE

CHLORDIAZEPOXIDE HCL

CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORPROMAZINE HCL

CITALOPRAM

CK-0569A (BULK) ANTI-PLAQUE AGENT

CLINDAMYCIN PHOSPHATE

CLOBAZAM

CLOMIPHENE CITRATE

CLONAZEPAM

CLORAZEPATE DIPOTASSIUM

CLOTRIMAZOLE

CMT

Chlordiazepoxide

Chlordiazepoxide hydrochloride Process 2

D.M.M.P.(1,3-BISMETHOXYMETHYL-5-ETHYL-5-PHENYL-BARBITURIC ACID)BULK

DESIPRAMINE HYDROCHLORIDE

DIAZEPAM

DIAZEPAM USP BULK

DILTIAZEM HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE (ALTERNATIVE PROCESS)

DUTASTERIDE

ELETRIPTAN HYDROBROMIDE

ENAMINE AMIDE (FIS0448)

ENCLOMIPHENE CITRATE

ENTACAPONE

ERLOTINIB HYDROCHLORIDE

ESLICARBAZEPINE ACETATE

ESMOLOL HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

ESTAZOLAM

ETHAMBUTOL DIHYDROCHLORIDE

FAMOTIDINE

FIS0127

FIS1174

FLUORESCEIN

FLURAZEPAM HCl

FLUVASTATIN SODIUM HYDRATE USP

FOSFOMYCIN TROMETAMOL

FURAZOLIDONE BULK

FUROSEMIDE

Flunitrazepam

Flunitrazepam Process 2

Flurazepam monohydrochloride

Fluvastatin sodium

GABAPENTIN

GENERAL INFORMATION ON FACILITIES & CONTROL

HALAZEPAM

IMATINIB MESYLATE

IMATINIB MESYLATE (ALPHA FORM)

IMATINIB MESYLATE (BETA FORM)

IMIPRAMINE HYDROCHLORIDE

INDOMETHACIN

INDOMETHACIN SODIUM

KETAZOLAM, BULK POWDER

KETOROLAC DERIVATIVE

KETOROLAC TROMETHAMINE

LAPATINIB DITOSYLATE

LENALIDOMIDE

LEVODOPA METHYL ESTER HYDROCHLORIDE

LORAZEPAM

LUBIPROSTONE

Lansoprazole

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALTE DI MONTECCHIO MAGGIORE.

METHAQUALONE BASE AND METHAQUALONE HCL

METHAZOLAMIDE

MIDAZOLAM HCI

MIRABEGRON

MONTELUKAST SODIUM THIOL ACID

N-[,3-5-DI(PYROLIDNYLMETHYL)-4-HYDROXY]BENZOYL ANILINE(A.CC.-9358)

NEBIVOLOL HYDROCHLORIDE

NIFEDIPINE

NIFEDIPINE USP

NILOTINIB DIHYDROCHLORIDE DIHYDRATE

NITROFURANTOIN & NITROFURANTOIN MACROCRYSTALS

NITROFURANTOIN MONOHYDRATE

NITROFURANTOIN MONOHYDRATE (CODE 1042)

Nitrazepam

OLOPATADINE HCI USP

OLOPATADINE HYDROCHLORIDE

OXAZEPAM

OXCARBAZEPINE

OXTRIPHYLLINE, BULK FORM

PENTAMIDINE ISETHIONATE

PENTAZOCINE

PENTAZOCINE HCI

PHENAZOPYRIDINE HYDROCHLORIDE (BULK POWDER)

PHENDIMETRAZINE BITARTRATE (BULK POWDER)

PIROXICAM

PRASTERONE ACETATE

PRAZEPAM

PROGESTERONE

PROPOFOL

PYRAZINAMIDE

PYRIDOSTIGMINE BROMIDE

QUAZEPAM--BULK DRUG

QUETIAPINE FUMARATE

RIFAXIMIN

ROSUVASTATIN CALCIUM

Rifaximin Form a

SERTRALINE HYDROCHLORIDE

SOLIFENACIN SUCCINATE

SORAFENIB HEMITOSYLATE

SUCCINYLCHOLINE CHLORIDE

SULINDAC

Sitagliptin phosphate hydrate

TACRINE HYDROCHLORIDE MONOHYDRATE

TEMAZEPAM

TERBINAFINE HCL

THALIDOMIDE

TOFACITINIB CITRATE

TOLBUTAMIDE (COARSE)

TOLBUTAMIDE (FINE)

TRIAMTERENE

TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOPRIM AF (ANILINE FREE)

TRIMETHOPRIM USP, BULK FORM

TSE 424 ACETATE

Tetrazepam

Tetrazepam Process 2

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Status - Active

Status - Inactive

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VALID

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217MF10541

217MF10542

217MF10543

217MF10544

217MF10847

217MF10849

218MF10197

218MF10792

220MF10010

220MF10166

220MF10202

221MF10106

222MF10163

223MF10009

223MF10124

224MF10199

226MF10001

226MF10082

226MF10165

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
OLOPATADINE HCI USP
Issue/Submission Date
2010-12-17
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 - Unpaid
DMF Review - N/A
 
Filing Details
OLOPATADINE HCI USP
Issue/Submission Date
2010-12-17
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FIS1174
Issue/Submission Date
2008-06-18
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
FIS1174
Issue/Submission Date
2008-06-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ACETYLCYSTEINE, USP
Issue/Submission Date
1983-07-04
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Acetylcysteine
Issue/Submission Date
2017-09-06
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
VALID
 
Filing Details
ACETYLCYSTEINE, USP
Acetylcysteine
Issue/Submission Date
1983-07-04
2017-09-06
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALLOPURINOL
Issue/Submission Date
1986-05-23
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ALLOPURINOL
Issue/Submission Date
1986-05-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMIODARONE HCL
Issue/Submission Date
1989-08-02
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 - Paid
DMF Review - N/A
 
Filing Details
AMIODARONE HCL
Issue/Submission Date
1989-08-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
N-[,3-5-DI(PYROLIDNYLMETHYL)-4-HYDR...
Issue/Submission Date
1986-01-14
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 - Paid
DMF Review - N/A
 
Filing Details
N-[,3-5-DI(PYROLIDNYLMETHYL)-4-HYDR...
Issue/Submission Date
1986-01-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APIXABAN
Issue/Submission Date
2016-03-14
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
APIXABAN
Issue/Submission Date
2016-03-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BENZYL HYDRAZINE MSA (FIS0181)
Issue/Submission Date
2007-08-07
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BENZYL HYDRAZINE MSA (FIS0181)
Issue/Submission Date
2007-08-07
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BRETYLIUM TOSYLATE, BULK FORM
Issue/Submission Date
1978-11-20
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 - Paid
DMF Review - N/A
 
Filing Details
BRETYLIUM TOSYLATE, BULK FORM
Issue/Submission Date
1978-11-20
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
Bromazepam
Issue/Submission Date
2014-02-24
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Bromazepam at Viale Milano 26 36075...
Issue/Submission Date
2008-07-24
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Bromazepam
Bromazepam at Viale Milano 26 36075...
Issue/Submission Date
2014-02-24
2008-07-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CARBAMAZEPINE
Issue/Submission Date
1986-10-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carbamazepine
Issue/Submission Date
2014-02-24
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
VALID
 
Filing Details
CARBAMAZEPINE
Carbamazepine
Issue/Submission Date
1986-10-20
2014-02-24
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
Chlordiazepoxide
Issue/Submission Date
2014-02-24
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
Chlordiazepoxide
Issue/Submission Date
2014-02-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CHLORDIAZEPOXIDE HCL
Issue/Submission Date
1962-02-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Chlordiazepoxide hydrochloride
Issue/Submission Date
2016-10-28
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Chlordiazepoxide at Viale Milano 26...
Issue/Submission Date
2010-06-02
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
CHLORDIAZEPOXIDE HCL
Chlordiazepoxide hydrochloride
Chlordiazepoxide at Viale Milano 26...
Issue/Submission Date
1962-02-15
2016-10-28
2010-06-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CHLORDIAZEPOXIDE HYDROCHLORIDE
Issue/Submission Date
1975-01-29
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CHLORDIAZEPOXIDE HYDROCHLORIDE
Issue/Submission Date
1975-01-29
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CHLORPROMAZINE HCL
Issue/Submission Date
1971-06-29
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
CHLORPROMAZINE HCL
Issue/Submission Date
1971-06-29
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CITALOPRAM
Issue/Submission Date
2003-07-21
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CITALOPRAM
Issue/Submission Date
2003-07-21
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLINDAMYCIN PHOSPHATE
Issue/Submission Date
1987-10-26
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 - Paid
DMF Review - N/A
 
Filing Details
CLINDAMYCIN PHOSPHATE
Issue/Submission Date
1987-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLINDAMYCIN PHOSPHATE
Issue/Submission Date
1998-09-01
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 - Paid
DMF Review - N/A
 
Filing Details
CLINDAMYCIN PHOSPHATE
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOBAZAM
Issue/Submission Date
2005-02-10
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CLOBAZAM
Issue/Submission Date
2005-02-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOBAZAM
Issue/Submission Date
2011-02-28
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CLOBAZAM
Issue/Submission Date
2011-02-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOMIPHENE CITRATE
Issue/Submission Date
1984-12-20
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Clomiphene citrate at Viale Milano ...
Issue/Submission Date
2014-05-02
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
CLOMIPHENE CITRATE
Clomiphene citrate at Viale Milano ...
Issue/Submission Date
1984-12-20
2014-05-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLONAZEPAM
Issue/Submission Date
1988-06-01
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Clonazepam Non-micronised, micronis...
Issue/Submission Date
2015-06-22
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Clonazepam at Viale Milano 26 36075...
Issue/Submission Date
2005-09-09
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
CLONAZEPAM
Clonazepam Non-micronised, micronis...
Clonazepam at Viale Milano 26 36075...
Issue/Submission Date
1988-06-01
2015-06-22
2005-09-09
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
Chlordiazepoxide hydrochloride Proc...
Issue/Submission Date
2016-11-18
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
Chlordiazepoxide hydrochloride Proc...
Issue/Submission Date
2016-11-18
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
CLORAZEPATE DIPOTASSIUM
Issue/Submission Date
1985-07-24
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
CLORAZEPATE DIPOTASSIUM
Issue/Submission Date
1985-07-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLOTRIMAZOLE
Issue/Submission Date
1988-06-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Clotrimazole Standard and micronise...
Issue/Submission Date
2016-02-18
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Clotrimazole at Viale Milano 26 360...
Issue/Submission Date
2005-11-01
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
CLOTRIMAZOLE
Clotrimazole Standard and micronise...
Clotrimazole at Viale Milano 26 360...
Issue/Submission Date
1988-06-21
2016-02-18
2005-11-01
Supporting Info

CMT

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
CMT
Issue/Submission Date
2003-12-19
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 - Paid
DMF Review - N/A
 
Filing Details
CMT
Issue/Submission Date
2003-12-19
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
DESIPRAMINE HYDROCHLORIDE
Issue/Submission Date
1988-03-22
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 - Paid
DMF Review - N/A
 
Filing Details
DESIPRAMINE HYDROCHLORIDE
Issue/Submission Date
1988-03-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DIAZEPAM
Issue/Submission Date
1978-02-28
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Diazepam
Issue/Submission Date
2014-02-24
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Diazepam at Viale Milano 26 36075 M...
Issue/Submission Date
2005-09-09
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
DIAZEPAM
Diazepam
Diazepam at Viale Milano 26 36075 M...
Issue/Submission Date
1978-02-28
2014-02-24
2005-09-09
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIAZEPAM USP BULK
Issue/Submission Date
1976-01-06
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
DIAZEPAM USP BULK
Issue/Submission Date
1976-01-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DILTIAZEM HYDROCHLORIDE
Issue/Submission Date
1988-07-18
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Diltiazem hydrochloride
Issue/Submission Date
2017-03-01
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
DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochloride
Issue/Submission Date
1988-07-18
2017-03-01
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DILTIAZEM HYDROCHLORIDE
Issue/Submission Date
1989-01-26
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 - Paid
DMF Review - N/A
 
Filing Details
DILTIAZEM HYDROCHLORIDE
Issue/Submission Date
1989-01-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DORZOLAMIDE HYDROCHLORIDE
Issue/Submission Date
2007-07-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Dorzolamide hydrochloride
Issue/Submission Date
2019-03-25
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
VALID
 
Filing Details
DORZOLAMIDE HYDROCHLORIDE
Dorzolamide hydrochloride
Issue/Submission Date
2007-07-27
2019-03-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DORZOLAMIDE HYDROCHLORIDE (ALTERNAT...
Issue/Submission Date
2015-07-24
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
DORZOLAMIDE HYDROCHLORIDE (ALTERNAT...
Issue/Submission Date
2015-07-24
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
DUTASTERIDE
Issue/Submission Date
2010-04-30
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 - Unpaid
DMF Review - N/A
 
Filing Details
DUTASTERIDE
Issue/Submission Date
2010-04-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ELETRIPTAN HYDROBROMIDE
Issue/Submission Date
2010-12-29
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ELETRIPTAN HYDROBROMIDE
Issue/Submission Date
2010-12-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ENCLOMIPHENE CITRATE
Issue/Submission Date
2017-05-25
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
ENCLOMIPHENE CITRATE
Issue/Submission Date
2017-05-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENTACAPONE
Issue/Submission Date
2010-07-13
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Entacapone
Issue/Submission Date
2016-07-01
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 - N/A
VALID
 
Filing Details
ENTACAPONE
Entacapone
Issue/Submission Date
2010-07-13
2016-07-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ERLOTINIB HYDROCHLORIDE
Issue/Submission Date
2017-12-18
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
ERLOTINIB HYDROCHLORIDE
Issue/Submission Date
2017-12-18
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
2017-06-05
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ESLICARBAZEPINE ACETATE
Issue/Submission Date
2017-06-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESMOLOL HYDROCHLORIDE
Issue/Submission Date
1982-03-12
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
ESMOLOL HYDROCHLORIDE
Issue/Submission Date
1982-03-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Issue/Submission Date
2011-04-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Esomeprazole magnesium dihydrate
Issue/Submission Date
2017-07-11
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
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Esomeprazole magnesium dihydrate
Issue/Submission Date
2011-04-20
2017-07-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESTAZOLAM
Issue/Submission Date
1995-12-20
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ESTAZOLAM
Issue/Submission Date
1995-12-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ETHAMBUTOL DIHYDROCHLORIDE
Issue/Submission Date
1990-05-28
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
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ETHAMBUTOL DIHYDROCHLORIDE
Issue/Submission Date
1990-05-28
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FAMOTIDINE
Issue/Submission Date
1989-08-30
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
FAMOTIDINE
Issue/Submission Date
1989-08-30
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
Flunitrazepam
Issue/Submission Date
2014-02-24
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
Flunitrazepam
Issue/Submission Date
2014-02-24
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
Flunitrazepam Process 2
Issue/Submission Date
2018-03-01
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
VALID
 
Filing Details
Flunitrazepam Process 2
Issue/Submission Date
2018-03-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FLUORESCEIN
Issue/Submission Date
2005-09-16
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
FLUORESCEIN
Issue/Submission Date
2005-09-16
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
Flurazepam monohydrochloride
Issue/Submission Date
2018-04-05
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
Flurazepam monohydrochloride
Issue/Submission Date
2018-04-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FLURAZEPAM HCl
Issue/Submission Date
1984-02-27
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Flurazepam hydrochloride at Viale M...
Issue/Submission Date
2006-10-06
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
FLURAZEPAM HCl
Flurazepam hydrochloride at Viale M...
Issue/Submission Date
1984-02-27
2006-10-06
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
Fluvastatin sodium at 9321 Airlie S...
Issue/Submission Date
2008-01-09
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Fluvastatin sodium at 9321 Airlie S...
Issue/Submission Date
2008-01-09
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