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FDA ANDA · ANDA073282

CLEMASTINE FUMARATE

Sponsor: ANI PHARMS

APPLICATION
ANDA073282
TYPE
ANDA
ORIGINAL APPROVAL
1992-01-31
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CLEMASTINE FUMARATEDiscontinued
CLEMASTINE FUMARATE 1.34MG · TABLET · ORAL
CLEMASTINE FUMARATEDiscontinued
CLEMASTINE FUMARATE 1.34MG · TABLET · ORAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 35AP
2000-08-02Manufacturing (CMC) · Supplement 33AP
2000-07-07Manufacturing (CMC) · Supplement 34AP
1998-07-01Manufacturing (CMC) · Supplement 32AP
1996-12-13Manufacturing (CMC) · Supplement 30AP
1996-11-26Manufacturing (CMC) · Supplement 31AP
1996-07-01Manufacturing (CMC) · Supplement 29AP
1996-02-27Labeling · Supplement 23AP
1996-01-25Manufacturing (CMC) · Supplement 25AP
1996-01-25Manufacturing (CMC) · Supplement 26AP
1996-01-25Manufacturing (CMC) · Supplement 24AP
1995-10-03Manufacturing (CMC) · Supplement 19AP
1995-10-03Manufacturing (CMC) · Supplement 17AP
1995-10-03Manufacturing (CMC) · Supplement 21AP
1995-10-03Manufacturing (CMC) · Supplement 18AP
1995-10-03Manufacturing (CMC) · Supplement 22AP
1995-10-03Manufacturing (CMC) · Supplement 20AP
1994-02-10Manufacturing (CMC) · Supplement 13AP
1994-01-26Manufacturing (CMC) · Supplement 15AP
1994-01-26Manufacturing (CMC) · Supplement 16AP
1994-01-26Manufacturing (CMC) · Supplement 14AP
1993-08-31Manufacturing (CMC) · Supplement 11AP
1993-08-31Manufacturing (CMC) · Supplement 10AP
1993-05-25Manufacturing (CMC) · Supplement 8AP
1993-05-25Manufacturing (CMC) · Supplement 6AP
1993-05-25Manufacturing (CMC) · Supplement 7AP
1993-05-07Manufacturing (CMC) · Supplement 4AP
1993-04-01Manufacturing (CMC) · Supplement 5AP
1993-03-08Manufacturing (CMC) · Supplement 1AP
1992-12-03Labeling · Supplement 2AP
1992-01-31OriginalAP
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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