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FDA NDA · NDA019649

FLUMADINE

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA019649
TYPE
NDA
ORIGINAL APPROVAL
1993-09-17
LATEST ACTION
2015-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLUMADINE · ReferenceDiscontinued
RIMANTADINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2015-10-19Manufacturing (CMC) · Supplement 18 · priorityAP
2010-04-05Labeling · Supplement 15 · unknown — Label ↗AP
2008-12-18Manufacturing (CMC) · Supplement 13 · priorityAP
2008-11-21Labeling · Supplement 14 · standard — Letter ↗AP
2008-01-08Labeling · Supplement 12 · standard — Letter ↗AP
2007-03-14Labeling · Supplement 10 · standard — Letter ↗AP
2001-04-06Labeling · Supplement 6 · standard — Label ↗AP
1999-11-08Manufacturing (CMC) · Supplement 4 · priorityAP
1997-10-14Manufacturing (CMC) · Supplement 3 · priorityAP
1995-02-16Manufacturing (CMC) · Supplement 1 · priorityAP
1993-09-17Type 1 - New Molecular Entity · Original · priorityAP
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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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