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Details for New Drug Application (NDA): 022247

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NDA 022247 describes DUAVEE, which is a drug marketed by Wyeth Pharms Pfizer and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the DUAVEE profile page.

The generic ingredient in DUAVEE is bazedoxifene acetate; estrogens, conjugated. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the bazedoxifene acetate; estrogens, conjugated profile page.

Summary for NDA: 022247

Formulation / Manufacturing:see details

Pharmacology for NDA: 022247

Suppliers and Packaging for NDA: 022247

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bazedoxifene acetate; estrogens, conjugated
TABLET;ORAL 022247 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-1123 0008-1123-12 1 POUCH in 1 CARTON (0008-1123-12) > 2 BLISTER PACK in 1 POUCH > 15 TABLET, FILM COATED in 1 BLISTER PACK
bazedoxifene acetate; estrogens, conjugated
TABLET;ORAL 022247 NDA U.S. Pharmaceuticals 63539-112 63539-112-07 1 BLISTER PACK in 1 CARTON (63539-112-07) > 7 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE;0.45MG
Approval Date:Oct 3, 2013TE:RLD:Yes
Patent:8,815,934Patent Expiration:May 6, 2019Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 3, 2016
Regulatory Exclusivity Use:NEW PRODUCT
Patent:5,998,402Patent Expiration:Apr 4, 2017Product Flag?YSubstance Flag?YDelist Request?

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