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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214154

NEXTSTELLIS (DROSPIRENONE; ESTETROL)
3MG;14.2MG
Marketing Status: Prescription
Active Ingredient: DROSPIRENONE; ESTETROL
Proprietary Name: NEXTSTELLIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG;14.2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214154
Product Number: 001
Approval Date: Apr 15, 2021
Applicant Holder Full Name: MAYNE PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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