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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Farmhispania, S.a.

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ASTEMIZOLE

ATRACURIUM BESYLATE USP

Abiraterone Acetate

Aprepitant

Atovaquone

Atropine

Atropine Sulfate

BENAZEPRIL HYDROCHLORIDE USP

Bortezomib

CAPTOPRIL

CISATRACURIUM BESYLATE USP

CROMOLYN SODIUM

Decitabine

Desloratadine

Dolasetron Mesylate

Dutetrabenazine

ENALAPRIL MALEATE

Enalaprilat

Enzalutamide

Everolimus

FEXOFENADINE HYDROCHLORIDE

FH-109 (MOEXIPRIL HYDROCHLORIDE)

FH-113 (RAMIPRIL)

FOSAPREPITANT DIMEGLUMINE

Flupirtine

Gefitinib

Gemcitabine hydrochloride

LISINOPRIL USP

Lisinopril dihydrate

Loratadine

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN.

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE / 0.75% COLLOIDAL SILICON DIOXIDE BLEND

MILRINONE

Methotrexate

Mivacurium

Pemetrexed

Pemetrexed sodium hemi-pentahydrate

Perindopril Arginine

Perindopril Erbumine

Pirfenidone

QUINAPRIL HYDROCHLORIDE (FH-106)

ROCURONIUM BROMIDE USP

Sirolimus

Solifenacin

Sugammadex sodium

Tacrolimus

Tetrabenazine

Tipiracil Hydrochloride

Trandolapril

Trifluridine

Vecuronium Bromide

palonosetron hydrochloride

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Status - Inactive

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VALID

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219MF10138

220MF10154

220MF10259

227MF10035

227MF10139

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USDMF

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Status
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CEP/COS

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Status
Filing Details
Issue/Submission Date
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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
 
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USDMF

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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
Supporting Info
Written Confirmation

Application Number
Status
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Issue/Submission Date
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Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ASTEMIZOLE
Issue/Submission Date
1996-10-22
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
ASTEMIZOLE
Issue/Submission Date
1996-10-22
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Status
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Issue/Submission Date
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Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
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Application Number
Status
 
Filing Details
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATRACURIUM BESYLATE USP
Issue/Submission Date
1995-07-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Atracurium besilate
Issue/Submission Date
2013-01-31
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
ATRACURIUM BESYLATE USP
Atracurium besilate
Issue/Submission Date
1995-07-31
2013-01-31
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USDMF

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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
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
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Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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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
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
BENAZEPRIL HYDROCHLORIDE USP
Issue/Submission Date
2001-05-04
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Benazepril hydrochloride
Issue/Submission Date
2016-01-26
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
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
BENAZEPRIL HYDROCHLORIDE USP
Benazepril hydrochloride
Issue/Submission Date
2001-05-04
2016-01-26
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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
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
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CAPTOPRIL
Issue/Submission Date
1991-07-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Captopril
Issue/Submission Date
2011-03-01
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CAPTOPRIL
Captopril
Issue/Submission Date
1991-07-31
2011-03-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CISATRACURIUM BESYLATE USP
Issue/Submission Date
2011-05-30
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Cisatracurium besilate
Issue/Submission Date
2017-10-11
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 - N/A
VALID
 
Filing Details
CISATRACURIUM BESYLATE USP
Cisatracurium besilate
Issue/Submission Date
2011-05-30
2017-10-11
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CROMOLYN SODIUM
Issue/Submission Date
1994-08-26
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
CROMOLYN SODIUM
Issue/Submission Date
1994-08-26
Supporting Info
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USDMF

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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

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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
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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
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 - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENALAPRIL MALEATE
Issue/Submission Date
1995-05-19
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Enalapril maleate
Issue/Submission Date
2013-03-14
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
ENALAPRIL MALEATE
Enalapril maleate
Issue/Submission Date
1995-05-19
2013-03-14
Supporting Info
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USDMF

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

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

Application Number
Status
 
Filing Details
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
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
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 - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FEXOFENADINE HYDROCHLORIDE
Issue/Submission Date
2001-06-22
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
FEXOFENADINE HYDROCHLORIDE
Issue/Submission Date
2001-06-22
Supporting Info
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USDMF

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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

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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
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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

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

Application Number
Status
VALID
Filing Details
Gefitinib
Issue/Submission Date
2017-11-03
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
Gefitinib
Issue/Submission Date
2017-11-03
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USDMF

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

Application Number
Status
VALID
Filing Details
Gemcitabine hydrochloride
Issue/Submission Date
2017-09-27
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Gemcitabine hydrochloride at Balmes...
Issue/Submission Date
2008-12-22
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Gemcitabine hydrochloride
Gemcitabine hydrochloride at Balmes...
Issue/Submission Date
2017-09-27
2008-12-22
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LISINOPRIL USP
Issue/Submission Date
1995-05-26
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LISINOPRIL USP
Issue/Submission Date
1995-05-26
Supporting Info
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USDMF

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

Application Number
Status
VALID
Filing Details
Lisinopril dihydrate
Issue/Submission Date
2015-04-02
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
Lisinopril dihydrate
Issue/Submission Date
2015-04-02
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
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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
METFORMIN HYDROCHLORIDE
Issue/Submission Date
1998-11-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Metformin Hydrochloride
Issue/Submission Date
2014-02-18
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Metformin hydrochloride at Balmes 8...
Issue/Submission Date
2008-06-30
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
METFORMIN HYDROCHLORIDE
Metformin Hydrochloride
Metformin hydrochloride at Balmes 8...
Issue/Submission Date
1998-11-24
2014-02-18
2008-06-30
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
METFORMIN HYDROCHLORIDE / 0.75% COL...
Issue/Submission Date
2012-08-06
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 - Paid
DMF Review - N/A
 
Filing Details
METFORMIN HYDROCHLORIDE / 0.75% COL...
Issue/Submission Date
2012-08-06
Supporting Info
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USDMF

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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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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MILRINONE
Issue/Submission Date
1999-07-01
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Milrinone at Balmes 85, Atico, 0800...
Issue/Submission Date
2007-04-18
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
MILRINONE
Milrinone at Balmes 85, Atico, 0800...
Issue/Submission Date
1999-07-01
2007-04-18
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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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Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FH-109 (MOEXIPRIL HYDROCHLORIDE)
Issue/Submission Date
2004-11-19
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
FH-109 (MOEXIPRIL HYDROCHLORIDE)
Issue/Submission Date
2004-11-19
Supporting Info
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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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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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Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Pemetrexed sodium hemi-pentahydrate...
Issue/Submission Date
2015-02-04
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Pemetrexed sodium hemi-pentahydrate...
Issue/Submission Date
2015-02-04
Supporting Info
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USDMF

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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

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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

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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
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
QUINAPRIL HYDROCHLORIDE (FH-106)
Issue/Submission Date
2003-07-25
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 - N/A
 
Filing Details
QUINAPRIL HYDROCHLORIDE (FH-106)
Issue/Submission Date
2003-07-25
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FH-113 (RAMIPRIL)
Issue/Submission Date
2005-07-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ramipril
Issue/Submission Date
2013-07-12
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
FH-113 (RAMIPRIL)
Ramipril
Issue/Submission Date
2005-07-15
2013-07-12
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ROCURONIUM BROMIDE USP
Issue/Submission Date
2006-09-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Rocuronium bromide
Issue/Submission Date
2013-07-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Rocuronium Bromide at Balmes 85, At...
Issue/Submission Date
2015-05-14
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
ROCURONIUM BROMIDE USP
Rocuronium bromide
Rocuronium Bromide at Balmes 85, At...
Issue/Submission Date
2006-09-15
2013-07-26
2015-05-14
Supporting Info
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USDMF

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

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

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

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

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

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

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

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Filing Details
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Supporting Info
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Application Number
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