Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020908

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VAGIFEM (ESTRADIOL)
10MCG
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: VAGIFEM
Dosage Form; Route of Administration: TABLET; VAGINAL
Strength: 10MCG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020908
Product Number: 002
Approval Date: Nov 25, 2009
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VAGIFEM (ESTRADIOL)
25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ESTRADIOL
Proprietary Name: VAGIFEM
Dosage Form; Route of Administration: TABLET; VAGINAL
Strength: 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020908
Product Number: 001
Approval Date: Mar 26, 1999
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information