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Last Updated: February 23, 2020

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Details for New Drug Application (NDA): 206863

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NDA 206863 describes DALFAMPRIDINE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma Ltd, Hikma, Micro Labs, and Sun Pharm, and is included in seven NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
Summary for 206863
Applicant:Accord Hlthcare
Formulation / Manufacturing:see details
Pharmacology for NDA: 206863
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 206863
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206863 ANDA Accord Healthcare Inc. 16729-292 16729-292-12 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16729-292-12)
DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206863 ANDA Golden State Medical Supply, Inc. 51407-246 51407-246-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51407-246-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jul 11, 2018TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 9, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

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