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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Catalent Pharma Solutions Llc

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211002432

ACCUTANE (10MG, 40MG)

ADVIL COLD AND SINUS LIQUID GELS

ADVIL LIQUI-GELS, 200 MG

ADVIL PM LIQUI-GELS

AMPRENAVIR 50 AND 150 MG SOFT GELATIN CAPSULES

AMR101 1G CAPSULES

ATRASENTAN HYDROCHLORIDE, SOFT GELATIN CAPSULES, 10 MG (BASE EQUIVALENT)

CALCITRIOL 0.25 MCG SOFT GELATIN CAPSULES

CALDEROL SOFTGELS 20MCG

DRISDOL SOFTGELS (ERGOCALCIFEROL, 50, 000 IU)

DRONABINOL CAPSULES USP 2.5MG, 5.0MG, 10.0MG (CIII) SA

DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES

DUTASTERIDE SOFT GELATIN CAPSULES .5MG

ESTRADIOL VAGINAL SOFT GELATIN CAPSULES

HECTOROL 2.5 UG, 1.0 UG, AND 0.5 UG CAPSULES

HYTRIN (TERAZOSIN) SOFT GELATIN CAPSULES

IBUPROFEN SOFTGELS, 200 MG.

LANOXICAPS (0.5, 0.10, AND 0.20MG) SOFTGEL CAPSULES

LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES

LORATADINE SOFTGELS (10 MG)

LOVAZA 1 G SOFT GELATIN CAPSULES(OMEGA-3-ACID ETHYL ESTERS, 1 GRAM)

LUBIPROSTONE, 24 MCG CAPSULES

MDV3100, 40MG, CAPSULES (SOFTGELS)

MICONAZOLE 1200 MG SOFTGELS

MICONAZOLE GELATIN ENCAPSULATED VAGINAL SUPPOSITORY 200 MG

MICONAZOLE NITRATE (1,200MG) VAGINAL OVULE SOFT-GELATIN CAPSULE

NEORAL 25 MG AND 100 MG SOFTGELS

NIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE

NIMODIPINE 30MG SOFTGEL CAPSULES

NIMODIPINE 30MG SOFTGELS

PALONOSETRON HC1 0.50 MG SOFTGELS (1.5 OVAL)

PALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS

PROCARDIA SOFTGELS 10 MG (NIFEDIPINE)

PROGESTERONE SOFT GELATIN CAPSULES 100 MG AND 200 MG

PROMETRIUM 100-MG AND 200-MG SOFT-GELATIN CAPSULE

R115866 SOFTGELS

RISPERIDONE 0.5 MG AND 1.0 MG ORALLY DISINTEGRATING TABLETS

RISPERIDONE 2.0 MG ORALLY DISINTEGRATING TABLETS

RITONAVIR, 100MG AND 200MG SOFT-GELATIN CAPSULE

ROCALTROL (0.25MCG & 0.5MCG) SOFTGEL CAPSULE

SANDIMMUNE 25 MG AND 100 MG SOFTGELS

SELEGILINE HYDROCHLORIDE ZYDIS TABLET 1.25MG

SOFT GELATIN CAPSULE - OET-10275258

SOFT GELATIN CAPSULE MANUFACTURING PROCESS FOR OET-10275167

SOFT GELATIN CAPSULE MANUFACTURING PROCESS FORMULA OET-10275188

SOFTGEL CAPSULE [OET-10275263]

SOFTGELS [0775279]

SOFTGELS [OET - 10258984]

SOFTGELS [OET - 10275485]

SOFTGELS [OET- 10275405-7]

SOFTGELS [OET-00775174]

SOFTGELS [OET-10258867]

SOFTGELS [OET-10259014]

SOFTGELS [OET-10259015-17]

SOFTGELS [OET-10275191]

SOFTGELS [OET-10275198]

SOFTGELS [OET-10275226]

SOFTGELS [OET-10275260]

SOFTGELS [OET-10275261]

SOFTGELS [OET-10275265]

SOFTGELS [OET-10275266]

SOFTGELS [OET-10275268]

SOFTGELS [OET-10275282]

SOFTGELS [OET-10275378]

SOFTGELS [OET-10275412]

SOFTGELS [OET-10275547-9]

SOFTGELS [OET:10275427-9]

TARGRETIN 75 MG SOFT-GELATIN CAPSULE

TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES

TIPRANAVIR CAPSULES 250 MG (IMPRINTED)

VESANOID, 10MG SOFTGELS

WC3042-05, CAPSULE

WC3042-08P CAPSULE

YXSORALEN-ULTRA SOFT GELATIN CAPSULES

ZARONTIN 0.25G SOFT GELATIN CAPSULES

ZEMPLAR (PARACALCITOL) CAPSULES, 1 MCG

ZEMPLAR (PARICALCITOL) 2 & 4 MCG CAPSULES

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ADVIL LIQUI-GELS, 200 MG
Issue/Submission Date
2008-11-21
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ADVIL LIQUI-GELS, 200 MG
Issue/Submission Date
2008-11-21
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMPRENAVIR 50 AND 150 MG SOFT GELAT...
Issue/Submission Date
1998-07-07
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
AMPRENAVIR 50 AND 150 MG SOFT GELAT...
Issue/Submission Date
1998-07-07
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATRASENTAN HYDROCHLORIDE, SOFT GELA...
Issue/Submission Date
2004-09-05
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ATRASENTAN HYDROCHLORIDE, SOFT GELA...
Issue/Submission Date
2004-09-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TESSALON 100 MG AND 200 MG SOFTGEL ...
Issue/Submission Date
1997-01-21
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TESSALON 100 MG AND 200 MG SOFTGEL ...
Issue/Submission Date
1997-01-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CALCITRIOL 0.25 MCG SOFT GELATIN CA...
Issue/Submission Date
2003-11-20
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CALCITRIOL 0.25 MCG SOFT GELATIN CA...
Issue/Submission Date
2003-11-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CALDEROL SOFTGELS 20MCG
Issue/Submission Date
2001-08-02
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
CALDEROL SOFTGELS 20MCG
Issue/Submission Date
2001-08-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
SANDIMMUNE 25 MG AND 100 MG SOFTGEL...
Issue/Submission Date
2005-11-30
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
SANDIMMUNE 25 MG AND 100 MG SOFTGEL...
Issue/Submission Date
2005-11-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DRONABINOL CAPSULES USP 2.5MG, 5.0M...
Issue/Submission Date
2010-05-27
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DRONABINOL CAPSULES USP 2.5MG, 5.0M...
Issue/Submission Date
2010-05-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
SOFT GELATIN CAPSULE MANUFACTURING ...
Issue/Submission Date
2010-12-10
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
SOFT GELATIN CAPSULE MANUFACTURING ...
Issue/Submission Date
2010-12-10
Supporting Info
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
SOFT GELATIN CAPSULE MANUFACTURING ...
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
SOFT GELATIN CAPSULE MANUFACTURING ...
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
SOFT GELATIN CAPSULE - OET-10275258
Issue/Submission Date
2012-12-31
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 - Paid
DMF Review - N/A
 
Filing Details
SOFT GELATIN CAPSULE - OET-10275258
Issue/Submission Date
2012-12-31
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DUTASTERIDE SOFT GELATIN CAPSULES ....
Issue/Submission Date
1999-12-22
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
DUTASTERIDE SOFT GELATIN CAPSULES ....
Issue/Submission Date
1999-12-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DUTASTERIDE 0.5 MG SOFT GELATIN CAP...
Issue/Submission Date
2010-10-19
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
DUTASTERIDE 0.5 MG SOFT GELATIN CAP...
Issue/Submission Date
2010-10-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMR101 1G CAPSULES
Issue/Submission Date
2011-09-12
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
AMR101 1G CAPSULES
Issue/Submission Date
2011-09-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DRISDOL SOFTGELS (ERGOCALCIFEROL, 5...
Issue/Submission Date
2001-07-13
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DRISDOL SOFTGELS (ERGOCALCIFEROL, 5...
Issue/Submission Date
2001-07-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ESTRADIOL VAGINAL SOFT GELATIN CAPS...
Issue/Submission Date
2009-06-08
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ESTRADIOL VAGINAL SOFT GELATIN CAPS...
Issue/Submission Date
2009-06-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
HECTOROL 2.5 UG, 1.0 UG, AND 0.5 UG...
Issue/Submission Date
1998-01-29
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
HECTOROL 2.5 UG, 1.0 UG, AND 0.5 UG...
Issue/Submission Date
1998-01-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
IBUPROFEN SOFTGELS, 200 MG.
Issue/Submission Date
1993-09-29
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IBUPROFEN SOFTGELS, 200 MG.
Issue/Submission Date
1993-09-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ADVIL COLD AND SINUS LIQUID GELS
Issue/Submission Date
2001-06-29
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ADVIL COLD AND SINUS LIQUID GELS
Issue/Submission Date
2001-06-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ADVIL PM LIQUI-GELS
Issue/Submission Date
2001-07-27
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 - Paid
DMF Review - N/A
 
Filing Details
ADVIL PM LIQUI-GELS
Issue/Submission Date
2001-07-27
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LOPINAVIR/RITONAVIR 133.3/33.3MG SO...
Issue/Submission Date
2000-03-29
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
LOPINAVIR/RITONAVIR 133.3/33.3MG SO...
Issue/Submission Date
2000-03-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LORATADINE SOFTGELS (10 MG)
Issue/Submission Date
2005-08-23
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LORATADINE SOFTGELS (10 MG)
Issue/Submission Date
2005-08-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LUBIPROSTONE, 24 MCG CAPSULES
Issue/Submission Date
2005-02-11
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
LUBIPROSTONE, 24 MCG CAPSULES
Issue/Submission Date
2005-02-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MDV3100, 40MG, CAPSULES (SOFTGELS)
Issue/Submission Date
2012-02-22
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 - N/A
 
Filing Details
MDV3100, 40MG, CAPSULES (SOFTGELS)
Issue/Submission Date
2012-02-22
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
MICONAZOLE GELATIN ENCAPSULATED VAG...
Issue/Submission Date
2006-11-08
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MICONAZOLE GELATIN ENCAPSULATED VAG...
Issue/Submission Date
2006-11-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MICONAZOLE 1200 MG SOFTGELS
Issue/Submission Date
2007-06-22
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 - N/A
 
Filing Details
MICONAZOLE 1200 MG SOFTGELS
Issue/Submission Date
2007-06-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MICONAZOLE NITRATE (1,200MG) VAGINA...
Issue/Submission Date
1998-04-08
Supporting Info
CEP/COS

Application Number
Status
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 - Paid
DMF Review - N/A
 
Filing Details
MICONAZOLE NITRATE (1,200MG) VAGINA...
Issue/Submission Date
1998-04-08
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
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NEORAL 25 MG AND 100 MG SOFTGELS
Issue/Submission Date
2005-04-13
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
NEORAL 25 MG AND 100 MG SOFTGELS
Issue/Submission Date
2005-04-13
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
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NIFEDIPINE (10MG AND 20MG) SOFTGEL ...
Issue/Submission Date
2001-02-15
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 - Paid
DMF Review - N/A
 
Filing Details
NIFEDIPINE (10MG AND 20MG) SOFTGEL ...
Issue/Submission Date
2001-02-15
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
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PROCARDIA SOFTGELS 10 MG (NIFEDIPIN...
Issue/Submission Date
2009-09-18
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 - N/A
 
Filing Details
PROCARDIA SOFTGELS 10 MG (NIFEDIPIN...
Issue/Submission Date
2009-09-18
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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NIMODIPINE 30MG SOFTGEL CAPSULES
Issue/Submission Date
2001-08-27
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
NIMODIPINE 30MG SOFTGEL CAPSULES
Issue/Submission Date
2001-08-27
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
NIMODIPINE 30MG SOFTGELS
Issue/Submission Date
2005-05-24
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
NIMODIPINE 30MG SOFTGELS
Issue/Submission Date
2005-05-24
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
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LOVAZA 1 G SOFT GELATIN CAPSULES(OM...
Issue/Submission Date
2000-01-26
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LOVAZA 1 G SOFT GELATIN CAPSULES(OM...
Issue/Submission Date
2000-01-26
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PALONOSETRON HC1 0.50 MG SOFTGELS (...
Issue/Submission Date
2012-09-18
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 - N/A
 
Filing Details
PALONOSETRON HC1 0.50 MG SOFTGELS (...
Issue/Submission Date
2012-09-18
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PALONOSETRON HYDROCHLORIDE 0.50 MG ...
Issue/Submission Date
2005-03-17
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
PALONOSETRON HYDROCHLORIDE 0.50 MG ...
Issue/Submission Date
2005-03-17
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ZEMPLAR (PARICALCITOL) 2 & 4 MCG CA...
Issue/Submission Date
2003-02-03
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
ZEMPLAR (PARICALCITOL) 2 & 4 MCG CA...
Issue/Submission Date
2003-02-03
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ZEMPLAR (PARACALCITOL) CAPSULES, 1 ...
Issue/Submission Date
2004-05-20
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
ZEMPLAR (PARACALCITOL) CAPSULES, 1 ...
Issue/Submission Date
2004-05-20
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PROGESTERONE SOFT GELATIN CAPSULES ...
Issue/Submission Date
2010-05-21
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
PROGESTERONE SOFT GELATIN CAPSULES ...
Issue/Submission Date
2010-05-21
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
R115866 SOFTGELS
Issue/Submission Date
2005-08-26
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
R115866 SOFTGELS
Issue/Submission Date
2005-08-26
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RISPERIDONE 0.5 MG AND 1.0 MG ORALL...
Issue/Submission Date
2003-11-19
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
RISPERIDONE 0.5 MG AND 1.0 MG ORALL...
Issue/Submission Date
2003-11-19
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
RISPERIDONE 2.0 MG ORALLY DISINTEGR...
Issue/Submission Date
2004-03-24
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RISPERIDONE 2.0 MG ORALLY DISINTEGR...
Issue/Submission Date
2004-03-24
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
RITONAVIR, 100MG AND 200MG SOFT-GEL...
Issue/Submission Date
1997-11-17
Supporting Info
CEP/COS

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

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

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RITONAVIR, 100MG AND 200MG SOFT-GEL...
Issue/Submission Date
1997-11-17
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ROCALTROL (0.25MCG & 0.5MCG) SOFTGE...
Issue/Submission Date
2001-02-28
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 - N/A
 
Filing Details
ROCALTROL (0.25MCG & 0.5MCG) SOFTGE...
Issue/Submission Date
2001-02-28
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USDMF

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Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
SELEGILINE HYDROCHLORIDE ZYDIS TABL...
Issue/Submission Date
2002-03-27
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
SELEGILINE HYDROCHLORIDE ZYDIS TABL...
Issue/Submission Date
2002-03-27
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TARGRETIN 75 MG SOFT-GELATIN CAPSUL...
Issue/Submission Date
1999-04-19
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
TARGRETIN 75 MG SOFT-GELATIN CAPSUL...
Issue/Submission Date
1999-04-19
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
HYTRIN (TERAZOSIN) SOFT GELATIN CAP...
Issue/Submission Date
1993-06-24
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 - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
HYTRIN (TERAZOSIN) SOFT GELATIN CAP...
Issue/Submission Date
1993-06-24
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TIPRANAVIR CAPSULES 250 MG (IMPRINT...
Issue/Submission Date
2004-10-26
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TIPRANAVIR CAPSULES 250 MG (IMPRINT...
Issue/Submission Date
2004-10-26
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
VESANOID, 10MG SOFTGELS
Issue/Submission Date
1994-06-28
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
VESANOID, 10MG SOFTGELS
Issue/Submission Date
1994-06-28
Supporting Info
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ZARONTIN 0.25G SOFT GELATIN CAPSULE...
Issue/Submission Date
2000-04-14
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 - N/A
 
Filing Details
ZARONTIN 0.25G SOFT GELATIN CAPSULE...
Issue/Submission Date
2000-04-14
Supporting Info
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PROMETRIUM 100-MG AND 200-MG SOFT-G...
Issue/Submission Date
2000-07-03
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
PROMETRIUM 100-MG AND 200-MG SOFT-G...