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FDA NDA · NDA019650

FLUMADINE

Sponsor: FOREST LABS

APPLICATION
NDA019650
TYPE
NDA
ORIGINAL APPROVAL
1993-09-17
LATEST ACTION
2008-01-08
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

FLUMADINEDiscontinued
RIMANTADINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL

Approval history

2008-01-08Labeling · Supplement 9 · standard — Letter ↗AP
2007-03-14Labeling · Supplement 7 · standard — Label ↗AP
2001-04-06Labeling · Supplement 4 · standard — Letter ↗AP
1999-11-08Manufacturing (CMC) · Supplement 2 · priorityAP
1993-09-17Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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