APPLICATION
ANDA040177
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-17
LATEST ACTION
2011-06-30
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Prescription
Products
TRIHEXYPHENIDYL HYDROCHLORIDEPrescription
TRIHEXYPHENIDYL HYDROCHLORIDE 2MG/5ML · ELIXIR · ORAL
Approval history
2011-06-30Labeling · Supplement 3AP
2010-10-04Labeling · Supplement 2AP
1997-04-17OriginalAP
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.