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 two suppliers. 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. Forty-six 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:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020908

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 020908

Estrogens

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:	DISCN	Dosage:	TABLET;VAGINAL			Strength	25MCG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Mar 26, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;VAGINAL			Strength	10MCG
Approval Date:	Nov 25, 2009	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Sep 17, 2022	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE

Expired US Patents for NDA 020908

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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
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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