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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208612

BALCOLTRA (ETHINYL ESTRADIOL; LEVONORGESTREL)
0.02MG;0.1MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; LEVONORGESTREL
Proprietary Name: BALCOLTRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.02MG;0.1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB3
Application Number: N208612
Product Number: 001
Approval Date: Jan 9, 2018
Applicant Holder Full Name: AVION PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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