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FDA NDA · NDA006773

ARTANE

Sponsor: LEDERLE

APPLICATION
NDA006773
TYPE
NDA
ORIGINAL APPROVAL
1949-05-13
LATEST ACTION
2003-06-25
ROUTE
ORAL
DOSAGE FORM
ELIXIR, TABLET, CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ARTANEDiscontinued
TRIHEXYPHENIDYL HYDROCHLORIDE 2MG/5ML · ELIXIR · ORAL
ARTANE · ReferenceDiscontinued
TRIHEXYPHENIDYL HYDROCHLORIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ARTANE · ReferenceDiscontinued
TRIHEXYPHENIDYL HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ARTANEDiscontinued
TRIHEXYPHENIDYL HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2003-06-25Labeling · Supplement 36 — Review ↗AP
1998-01-28Manufacturing (CMC) · Supplement 35AP
1997-07-02Manufacturing (CMC) · Supplement 33AP
1997-07-02Manufacturing (CMC) · Supplement 34AP
1997-07-02Manufacturing (CMC) · Supplement 32AP
1997-02-19Manufacturing (CMC) · Supplement 29AP
1997-02-19Manufacturing (CMC) · Supplement 31AP
1997-02-19Manufacturing (CMC) · Supplement 30AP
1996-12-17Manufacturing (CMC) · Supplement 28AP
1996-08-27Manufacturing (CMC) · Supplement 27AP
1993-06-25Manufacturing (CMC) · Supplement 26AP
1987-07-24Labeling · Supplement 22AP
1987-02-26Labeling · Supplement 23AP
1984-06-26Manufacturing (CMC) · Supplement 21AP
1976-03-11Manufacturing (CMC) · Supplement 17AP
1976-03-11Manufacturing (CMC) · Supplement 16AP
1976-03-10Manufacturing (CMC) · Supplement 18AP
1976-01-28Manufacturing (CMC) · Supplement 15AP
1976-01-27REMS · Supplement 9AP
1975-03-11Manufacturing (CMC) · Supplement 13AP
1975-03-10Manufacturing (CMC) · Supplement 14AP
1975-01-29Labeling · Supplement 10AP
1949-05-13OriginalAP
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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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