APPLICATION
ANDA085944
TYPE
ANDA
ORIGINAL APPROVAL
1977-09-29
LATEST ACTION
1993-08-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
1993-08-24Labeling · Supplement 27AP
1993-03-11Labeling · Supplement 26AP
1991-04-26Labeling · Supplement 25AP
1988-03-30Labeling · Supplement 20AP
1977-09-29OriginalAP
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.