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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217424

EQ 10.3% BASE
Marketing Status: Prescription
Active Ingredient: BERDAZIMER SODIUM
Proprietary Name: ZELSUVMI
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: EQ 10.3% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217424
Product Number: 001
Approval Date: Jan 5, 2024
Applicant Holder Full Name: LNHC INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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