← FDA DRUG APPROVALS

FDA ANDA · ANDA089423

AMITRIPTYLINE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA089423
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-17
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 150MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 21AP
1995-10-16Labeling · Supplement 20AP
1994-12-23Manufacturing (CMC) · Supplement 19AP
1994-10-11Manufacturing (CMC) · Supplement 18AP
1993-09-03Labeling · Supplement 17AP
1992-04-03Manufacturing (CMC) · Supplement 16AP
1992-04-03Manufacturing (CMC) · Supplement 14AP
1992-01-31Labeling · Supplement 13AP
1991-12-30Labeling · Supplement 12AP
1991-05-01Manufacturing (CMC) · Supplement 8AP
1991-05-01Manufacturing (CMC) · Supplement 11AP
1991-05-01Manufacturing (CMC) · Supplement 9AP
1991-05-01Manufacturing (CMC) · Supplement 10AP
1990-02-28Manufacturing (CMC) · Supplement 6AP
1988-06-14Manufacturing (CMC) · Supplement 5AP
1988-02-12Manufacturing (CMC) · Supplement 4AP
1987-03-27Manufacturing (CMC) · Supplement 1AP
1987-02-17OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →