← FDA DRUG APPROVALS

FDA ANDA · ANDA071079

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA071079
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-12
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 4MG · TABLET · ORAL

Approval history

2025-06-24Labeling · Supplement 31 · standardAP
2025-01-22Labeling · Supplement 30 · standardAP
2017-02-23Labeling · Supplement 29 · standardAP
2016-04-25Labeling · Supplement 28 · standardAP
2014-07-17Labeling · Supplement 27 · standardAP
2010-09-30Labeling · Supplement 26AP
1998-12-01Manufacturing (CMC) · Supplement 25AP
1995-09-19Labeling · Supplement 24AP
1994-12-23Manufacturing (CMC) · Supplement 23AP
1994-10-11Manufacturing (CMC) · Supplement 22AP
1993-10-19Labeling · Supplement 21AP
1992-04-03Manufacturing (CMC) · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 20AP
1991-01-22Manufacturing (CMC) · Supplement 10AP
1991-01-22Labeling · Supplement 9AP
1990-05-03Bioequivalence · Supplement 14AP
1989-11-28Labeling · Supplement 12AP
1989-01-06Manufacturing (CMC) · Supplement 8AP
1989-01-06Manufacturing (CMC) · Supplement 6AP
1989-01-06Manufacturing (CMC) · Supplement 7AP
1989-01-06Manufacturing (CMC) · Supplement 5AP
1988-01-26Manufacturing (CMC) · Supplement 3AP
1986-11-12OriginalAP
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 →