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Last Updated: July 15, 2020

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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 one supplier. There is one patent 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 020908
Applicant:Novo Nordisk Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 020908
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 020908
Suppliers and Packaging for NDA: 020908
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VAGIFEM estradiol TABLET;VAGINAL 020908 NDA Novo Nordisk 0169-5176 0169-5176-03 8 APPLICATOR in 1 CARTON (0169-5176-03) > 1 INSERT in 1 APPLICATOR
VAGIFEM estradiol TABLET;VAGINAL 020908 NDA Novo Nordisk 0169-5176 0169-5176-04 18 APPLICATOR in 1 CARTON (0169-5176-04) > 1 INSERT in 1 APPLICATOR
Paragraph IV (Patent) Challenges for 020908
Tradename Dosage Ingredient NDA Submissiondate
VAGIFEM TABLET;VAGINAL estradiol 020908 2013-01-02

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;VAGINALStrength10MCG
Approval Date:Nov 25, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Sep 17, 2022Product Flag?Substance Flag?Delist Request?

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