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Last Updated: November 2, 2024

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. 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-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 020908
Tradename:VAGIFEM
Applicant:Novo Nordisk Inc
Ingredient:estradiol
Patents:0
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

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Expired US Patents for NDA 020908

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc VAGIFEM estradiol TABLET;VAGINAL 020908-002 Nov 25, 2009 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VAGIFEM estradiol TABLET;VAGINAL 020908-002 Nov 25, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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