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FDA ANDA · ANDA074512

CLEMASTINE FUMARATE

Sponsor: L PERRIGO CO

APPLICATION
ANDA074512
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-22
LATEST ACTION
2002-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CLEMASTINE FUMARATEDiscontinued
CLEMASTINE FUMARATE 1.34MG · TABLET · ORAL

Approval history

2002-12-13Manufacturing (CMC) · Supplement 7AP
2002-12-13Manufacturing (CMC) · Supplement 8AP
2002-11-21Labeling · Supplement 6AP
2001-03-23Manufacturing (CMC) · Supplement 5AP
2001-03-23Manufacturing (CMC) · Supplement 4AP
2000-01-27Labeling · Supplement 3AP
1997-07-09Manufacturing (CMC) · Supplement 2AP
1997-07-09Manufacturing (CMC) · Supplement 1AP
1995-11-22OriginalAP
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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