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FDA ANDA · ANDA062483

GRIFULVIN V

Sponsor: VALEANT LUXEMBOURG

APPLICATION
ANDA062483
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-26
LATEST ACTION
2015-11-02
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

GRIFULVIN VDiscontinued
GRISEOFULVIN, MICROSIZE 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2015-11-02Labeling · Supplement 21AP
2002-10-17Manufacturing (CMC) · Supplement 17AP
2002-02-11Manufacturing (CMC) · Supplement 16AP
1998-12-30Manufacturing (CMC) · Supplement 15 — Review ↗AP
1998-09-21Manufacturing (CMC) · Supplement 14 — Review ↗AP
1997-08-13Supplement · Supplement 13 — Review ↗AP
1997-03-21Supplement · Supplement 7 — Review ↗AP
1995-11-22Manufacturing (CMC) · Supplement 12 — Review ↗AP
1995-11-06Supplement · Supplement 6 — Review ↗AP
1994-08-29Supplement · Supplement 2 — Review ↗AP
1994-03-17Supplement · Supplement 5 — Review ↗AP
1993-04-13Labeling · Supplement 11 — Review ↗AP
1992-07-14Labeling · Supplement 10 — Review ↗AP
1992-03-03Supplement · Supplement 4 — Review ↗AP
1991-09-17Manufacturing (CMC) · Supplement 9 — Review ↗AP
1991-03-03Supplement · Supplement 3 — Review ↗AP
1990-04-12Supplement · Supplement 1 — Review ↗AP
1990-03-22Manufacturing (CMC) · Supplement 8 — Review ↗AP
1984-01-26Original — 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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