APPLICATION
ANDA089514
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-07
LATEST ACTION
1998-02-06
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
TRIHEXYPHENIDYL HYDROCHLORIDEDiscontinued
TRIHEXYPHENIDYL HYDROCHLORIDE 2MG/5ML · ELIXIR · ORAL
Approval history
1998-02-06Labeling · Supplement 2AP
1994-02-22Manufacturing (CMC) · Supplement 1AP
1989-04-07OriginalAP
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.