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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208292


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NDA 208292 describes DALFAMPRIDINE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma, Hikma, Micro Labs, Rising, and Sun Pharm, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DALFAMPRIDINE profile page.

The generic ingredient in DALFAMPRIDINE is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
Summary for 208292
Tradename:DALFAMPRIDINE
Applicant:Sun Pharm
Ingredient:dalfampridine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208292
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 208292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 208292 ANDA Sun Pharmaceutical Industries, Inc. 62756-429 62756-429-86 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 21, 2019TE:ABRLD:No

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