← FDA DRUG APPROVALS

FDA NDA · NDA011702

EQUAGESIC

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
NDA011702
TYPE
NDA
ORIGINAL APPROVAL
1960-05-27
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

EQUAGESICDiscontinued
ASPIRIN 325MG, MEPROBAMATE 200MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 41 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 40 · standard — Letter ↗AP
2006-03-22Manufacturing (CMC) · Supplement 37 · standardAP
2003-05-19Labeling · Supplement 36 · standardAP
1988-01-27Manufacturing (CMC) · Supplement 33 · standardAP
1988-01-22Manufacturing (CMC) · Supplement 32 · standardAP
1987-06-08Manufacturing (CMC) · Supplement 31 · standardAP
1986-08-12Manufacturing (CMC) · Supplement 30 · standardAP
1985-10-29Labeling · Supplement 29AP
1983-12-29Labeling · Supplement 28AP
1983-09-19Manufacturing (CMC) · Supplement 27 · standardAP
1981-03-06Manufacturing (CMC) · Supplement 24 · standardAP
1978-12-15Manufacturing (CMC) · Supplement 18 · standardAP
1978-12-15Manufacturing (CMC) · Supplement 19 · standardAP
1978-12-15Manufacturing (CMC) · Supplement 17 · standardAP
1978-09-20Labeling · Supplement 20AP
1975-04-22Labeling · Supplement 5AP
1960-05-27Type 4 - New Combination · Original · standardAP
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 →