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FDA ANDA · ANDA080259

PROMPT PHENYTOIN SODIUM

Sponsor: ANI PHARMS

APPLICATION
ANDA080259
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-06
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROMPT PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 100MG PROMPT · CAPSULE · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 49AP
2002-03-12Manufacturing (CMC) · Supplement 48AP
2000-03-28Manufacturing (CMC) · Supplement 47AP
2000-01-28Manufacturing (CMC) · Supplement 46AP
1999-11-23Manufacturing (CMC) · Supplement 45AP
1999-08-20Manufacturing (CMC) · Supplement 44AP
1998-12-09Manufacturing (CMC) · Supplement 43AP
1997-05-30Manufacturing (CMC) · Supplement 42AP
1993-04-30Manufacturing (CMC) · Supplement 41AP
1993-02-23Manufacturing (CMC) · Supplement 40AP
1993-02-23Manufacturing (CMC) · Supplement 39AP
1992-07-17Labeling · Supplement 38AP
1989-08-07Labeling · Supplement 37AP
1989-06-26Manufacturing (CMC) · Supplement 36AP
1987-09-10Manufacturing (CMC) · Supplement 34AP
1987-09-10Manufacturing (CMC) · Supplement 35AP
1987-04-13Manufacturing (CMC) · Supplement 32AP
1987-04-13Manufacturing (CMC) · Supplement 33AP
1987-04-13Manufacturing (CMC) · Supplement 31AP
1978-04-06OriginalAP
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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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