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Details for New Drug Application (NDA): 020908

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NDA 020908 describes VAGIFEM, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VAGIFEM profile page.

The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 020908

Pharmacology for NDA: 020908

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 020908

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;VAGINAL 020908 NDA Novo Nordisk 0169-5176 0169-5176-03 8 APPLICATOR in 1 CARTON (0169-5176-03) > 1 INSERT in 1 APPLICATOR
TABLET;VAGINAL 020908 NDA Novo Nordisk 0169-5176 0169-5176-04 18 APPLICATOR in 1 CARTON (0169-5176-04) > 1 INSERT in 1 APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;VAGINALStrength25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 26, 1999TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;VAGINALStrength10MCG
Approval Date:Nov 25, 2009TE:ABRLD:Yes
Patent:5,860,946Patent Expiration:Jul 1, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:7,018,992Patent Expiration:Sep 17, 2022Product Flag?Substance Flag?Delist Request?

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