APPLICATION
NDA009193
TYPE
NDA
ORIGINAL APPROVAL
1954-03-05
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
COGENTIN · ReferenceDiscontinued
BENZTROPINE MESYLATE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
COGENTIN · ReferenceDiscontinued
BENZTROPINE MESYLATE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
COGENTIN · ReferenceDiscontinued
BENZTROPINE MESYLATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2009-03-13Labeling · Supplement 39 · standardAP
2009-03-13Labeling · Supplement 19AP
2009-03-13Labeling · Supplement 33AP
2009-03-13Labeling · Supplement 15AP
2009-03-13Labeling · Supplement 38 · standardAP
2009-03-13Labeling · Supplement 24AP
1996-09-26Labeling · Supplement 34AP
1996-04-15Manufacturing (CMC) · Supplement 36 · priorityAP
1994-06-01Manufacturing (CMC) · Supplement 35 · priorityAP
1988-04-08Manufacturing (CMC) · Supplement 32 · priorityAP
1988-01-20Manufacturing (CMC) · Supplement 31 · priorityAP
1986-08-25Manufacturing (CMC) · Supplement 30 · priorityAP
1986-01-14Labeling · Supplement 29AP
1984-09-13Manufacturing (CMC) · Supplement 28 · priorityAP
1984-08-15Manufacturing (CMC) · Supplement 27 · priorityAP
1982-09-03Manufacturing (CMC) · Supplement 25 · priorityAP
1982-09-03Manufacturing (CMC) · Supplement 26 · priorityAP
1981-06-02Manufacturing (CMC) · Supplement 23 · priorityAP
1981-05-14Manufacturing (CMC) · Supplement 22 · priorityAP
1980-05-01Manufacturing (CMC) · Supplement 18 · priorityAP
1979-10-05Labeling · Supplement 21AP
1979-04-19Labeling · Supplement 20AP
1977-05-05Labeling · Supplement 16AP
1977-03-01Manufacturing (CMC) · Supplement 17 · priorityAP
1975-01-15Labeling · Supplement 14AP
1974-07-01REMS · Supplement 10 · priorityAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.