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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021040

PREFEST (ESTRADIOL; NORGESTIMATE)
1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESTRADIOL; NORGESTIMATE
Proprietary Name: PREFEST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021040
Product Number: 001
Approval Date: Oct 22, 1999
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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