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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076064

JUNEL FE 1.5/30 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE)
0.03MG;1.5MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Proprietary Name: JUNEL FE 1.5/30
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.03MG;1.5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A076064
Product Number: 001
Approval Date: Sep 18, 2003
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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