APPLICATION
ANDA085815
TYPE
ANDA
ORIGINAL APPROVAL
1978-05-11
LATEST ACTION
1993-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
1993-06-28Labeling · Supplement 34AP
1991-12-17Labeling · Supplement 33AP
1988-03-23Labeling · Supplement 30AP
1978-05-11OriginalAP
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.