Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208078

FIRDAPSE (AMIFAMPRIDINE PHOSPHATE)
EQ 10MG BASE Marketing Status: Prescription

Active Ingredient: AMIFAMPRIDINE PHOSPHATE
Proprietary Name: FIRDAPSE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208078
Product Number: 001
Approval Date: Nov 28, 2018
Applicant Holder Full Name: CATALYST PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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