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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216285

DROSPIRENONE (DROSPIRENONE)
3.5MG
Marketing Status: Prescription
Active Ingredient: DROSPIRENONE
Proprietary Name: DROSPIRENONE
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 3.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216285
Product Number: 001
Approval Date: Jun 29, 2022
Applicant Holder Full Name: EXELTIS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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