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FDA ANDA · ANDA073399

CLEMASTINE FUMARATE

Sponsor: GENUS

APPLICATION
ANDA073399
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-30
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

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

Approval history

2001-08-30Manufacturing (CMC) · Supplement 17AP
2000-07-07Manufacturing (CMC) · Supplement 16AP
1999-12-09Manufacturing (CMC) · Supplement 15AP
1998-04-15Manufacturing (CMC) · Supplement 12AP
1997-10-30Manufacturing (CMC) · Supplement 11AP
1997-10-30Manufacturing (CMC) · Supplement 14AP
1997-05-05Manufacturing (CMC) · Supplement 13AP
1995-10-02Manufacturing (CMC) · Supplement 9AP
1995-10-02Manufacturing (CMC) · Supplement 7AP
1995-10-02Manufacturing (CMC) · Supplement 5AP
1995-10-02Manufacturing (CMC) · Supplement 10AP
1995-10-02Manufacturing (CMC) · Supplement 8AP
1995-10-02Manufacturing (CMC) · Supplement 6AP
1995-06-29Manufacturing (CMC) · Supplement 3AP
1995-06-29Manufacturing (CMC) · Supplement 4AP
1995-05-04Manufacturing (CMC) · Supplement 1AP
1995-05-04Manufacturing (CMC) · Supplement 2AP
1994-06-30OriginalAP
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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