FDA ANDA · ANDA073095

CLEMASTINE FUMARATE

Sponsor: TEVA PHARMS

APPLICATION

ANDA073095

TYPE

ANDA

ORIGINAL APPROVAL

1992-04-21

LATEST ACTION

1999-03-23

ROUTE

ORAL

DOSAGE FORM

SYRUP

MARKETING STATUS

Discontinued

Products

CLEMASTINE FUMARATEDiscontinued

CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML · SYRUP · ORAL

1999-03-23Manufacturing (CMC) · Supplement 10AP

1998-10-08Manufacturing (CMC) · Supplement 9AP

1998-05-13Manufacturing (CMC) · Supplement 8AP

1996-05-31Manufacturing (CMC) · Supplement 7AP

1995-08-15Labeling · Supplement 5AP

1995-08-15Manufacturing (CMC) · Supplement 3AP

1995-08-15Manufacturing (CMC) · Supplement 4AP

1994-10-20Labeling · Supplement 6AP

1994-05-23Manufacturing (CMC) · Supplement 2AP

1992-04-21OriginalAP

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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