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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076198

BALZIVA-21 (ETHINYL ESTRADIOL; NORETHINDRONE)
0.035MG;0.4MG
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: BALZIVA-21
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.035MG;0.4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076198
Product Number: 001
Approval Date: Apr 22, 2004
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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