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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 020527


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NDA 020527 describes PREMPRO, which is a drug marketed by Wyeth Pharms and Wyeth Pharms Inc and is included in two NDAs. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.
Summary for 020527
Pharmacology for NDA: 020527
Mechanism of ActionEstrogen Receptor Agonists
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 LLC, 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 LLC, a subsidiary of Pfizer Inc. 0046-1106 0046-1106-11 1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK

Profile for product number 001

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

Profile 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

Profile for product number 003

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

Expired US Patents for NDA 020527

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