APPLICATION
ANDA088894
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-11
LATEST ACTION
2002-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BENZTROPINE MESYLATEDiscontinued
BENZTROPINE MESYLATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-05-28Labeling · Supplement 25AP
2000-11-30Manufacturing (CMC) · Supplement 24AP
2000-07-26Manufacturing (CMC) · Supplement 23AP
1998-07-02Manufacturing (CMC) · Supplement 20AP
1998-07-02Manufacturing (CMC) · Supplement 17AP
1998-02-27Labeling · Supplement 22AP
1997-11-26Manufacturing (CMC) · Supplement 18AP
1997-11-26Manufacturing (CMC) · Supplement 19AP
1994-05-27Manufacturing (CMC) · Supplement 13AP
1993-10-19Labeling · Supplement 16AP
1991-08-28Labeling · Supplement 15AP
1991-06-12Labeling · Supplement 12AP
1988-12-29Manufacturing (CMC) · Supplement 9AP
1988-12-29Manufacturing (CMC) · Supplement 10AP
1988-12-29Manufacturing (CMC) · Supplement 11AP
1986-04-29Manufacturing (CMC) · Supplement 5AP
1986-04-29Manufacturing (CMC) · Supplement 4AP
1985-12-19Manufacturing (CMC) · Supplement 3AP
1985-12-19Manufacturing (CMC) · Supplement 2AP
1985-04-11OriginalAP
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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