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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016936

DEMULEN 1/50-28 (ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE)
0.05MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
Proprietary Name: DEMULEN 1/50-28
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.05MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N016936
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GD SEARLE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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