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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020527

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NDA 020527 describes PREMPRO, which is a drug marketed by Wyeth Pharms Inc and is included in two NDAs. It is available from four suppliers. Additional details are available on the PREMPRO profile page.

The generic ingredient in PREMPRO is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.

Summary for NDA: 020527

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020527

Suppliers and Packaging for NDA: 020527

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREMPHASE 14/14
estrogens, conjugated; medroxyprogesterone acetate
TABLET;ORAL-28 020527 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0046-1105 0046-1105-11 1 BLISTER PACK in 1 CARTON (0046-1105-11) > 28 TABLET, SUGAR COATED in 1 BLISTER PACK
PREMPHASE 14/14
estrogens, conjugated; medroxyprogesterone acetate
TABLET;ORAL-28 020527 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0046-1105 0046-1105-51 1 POUCH in 1 CARTON (0046-1105-51) > 1 BLISTER PACK in 1 POUCH > 5 TABLET, SUGAR COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.625MG;2.5MG
Approval Date:Nov 17, 1995TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.625MG,0.625MG;N/A,5MG
Approval Date:Nov 17, 1995TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.625MG;5MG
Approval Date:Jan 9, 1998TE:RLD:Yes

Expired Orange Book Patents for NDA: 020527



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