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FDA NDA · NDA012015

COGENTIN

Sponsor: EPIC PHARMA LLC

APPLICATION
NDA012015
TYPE
NDA
ORIGINAL APPROVAL
1959-12-21
LATEST ACTION
2015-02-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

COGENTIN · ReferenceDiscontinued
BENZTROPINE MESYLATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2022-08-06Manufacturing (CMC) · Supplement 36 — Letter ↗TA
2015-02-03Manufacturing (CMC) · Supplement 32 · standardAP
2013-06-26Manufacturing (CMC) · Supplement 31 · standardAP
2013-04-22Labeling · Supplement 27 · standard — Label ↗AP
2013-04-22Labeling · Supplement 26 · standard — Letter ↗AP
2001-05-22Labeling · Supplement 23 · standard — Letter ↗AP
1998-07-27Manufacturing (CMC) · Supplement 25 · standardAP
1998-07-24Manufacturing (CMC) · Supplement 24 · standardAP
1996-09-26Labeling · Supplement 21AP
1996-04-15Manufacturing (CMC) · Supplement 22 · standardAP
1988-10-31Manufacturing (CMC) · Supplement 19 · standardAP
1986-01-14Labeling · Supplement 18AP
1981-11-02Manufacturing (CMC) · Supplement 16 · standardAP
1981-10-19Manufacturing (CMC) · Supplement 15 · standardAP
1981-05-14Manufacturing (CMC) · Supplement 14 · standardAP
1979-04-19Labeling · Supplement 13AP
1977-05-05Labeling · Supplement 11AP
1975-01-15Labeling · Supplement 9AP
1974-07-01REMS · Supplement 6 · standardAP
1959-12-21Type 3 - New Dosage Form · Original · standardAP
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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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