APPLICATION
NDA012947
TYPE
NDA
ORIGINAL APPROVAL
1962-04-18
LATEST ACTION
1993-06-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ARTANEDiscontinued
TRIHEXYPHENIDYL HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1993-06-15Manufacturing (CMC) · Supplement 22 · standardAP
1987-07-24Labeling · Supplement 19 · standardAP
1987-02-26Labeling · Supplement 20 · standardAP
1984-06-26Manufacturing (CMC) · Supplement 18 · standardAP
1982-07-22Manufacturing (CMC) · Supplement 17 · standardAP
1977-02-08Efficacy · Supplement 11 · standardAP
1962-04-18Type 3 - New Dosage Form · Original · standardAP
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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