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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078376

GILDAGIA (ETHINYL ESTRADIOL; NORETHINDRONE)
0.035MG;0.4MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: GILDAGIA
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG;0.4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078376
Product Number: 001
Approval Date: Nov 6, 2012
Applicant Holder Full Name: VINTAGE PHARMACEUTICALS
Marketing Status:  Prescription
Patent and Exclusivity Information
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