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DALFAMPRIDINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2018-07-30

Drug application

FDA Application #

ANDA206765

Application type

Abbreviated New Drug Application (Generic)

Brand name

DALFAMPRIDINE

Generic name

DALFAMPRIDINE

Active ingredients

DALFAMPRIDINE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2018-07-30

Source

Authoritative

Drugs@FDA application overview

Machine

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