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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091692

DOLISHALE (ETHINYL ESTRADIOL; LEVONORGESTREL)
0.02MG;0.09MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; LEVONORGESTREL
Proprietary Name: DOLISHALE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.02MG;0.09MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091692
Product Number: 001
Approval Date: Oct 22, 2020
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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