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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215904

ZTALMY (GANAXOLONE)
50MG/ML
Marketing Status: Prescription
Active Ingredient: GANAXOLONE
Proprietary Name: ZTALMY
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 50MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215904
Product Number: 001
Approval Date: Jun 1, 2022
Applicant Holder Full Name: MARINUS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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