← FDA DRUG APPROVALS

FDA NDA · NDA022250

AMPYRA

dalfampridine

Sponsor: MERZ

APPLICATION
NDA022250
TYPE
NDA
ORIGINAL APPROVAL
2010-01-22
LATEST ACTION
2021-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

AMPYRA · ReferencePrescription
DALFAMPRIDINE 10MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-11-18Labeling · Supplement 19 · standard — Label ↗AP
2021-02-24Labeling · Supplement 18 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 17 · standard — Label ↗AP
2017-09-29Labeling · Supplement 15 · standard — Label ↗AP
2016-10-13Labeling · Supplement 13 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 1 · priorityAP
2014-08-22Manufacturing (CMC) · Supplement 10 · priorityAP
2013-06-18REMS · Supplement 8 — Letter ↗AP
2013-01-22Labeling · Supplement 6 · standard — Label ↗AP
2012-12-21Labeling · Supplement 7 · standard — Label ↗AP
2012-07-20Labeling · Supplement 4 · standard — Letter ↗AP
2012-07-20Labeling · Supplement 3 · priority — Label ↗AP
2011-11-17REMS · Supplement 2 — Letter ↗AP
2010-01-22Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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