Equagesic

NDA 11702, held by Sun Pharm Industries. Aspirin; Meprobamate.

As of Nov 13, 2026, NDA 11702 (Equagesic), held by Sun Pharm Industries, was first approved by FDA on May 27, 1960, with 17 approved supplements and 0 published complete response letters.

First approved: May 27, 1960
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
May 27, 1960	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Equagesic325MG;200MG · tablet;oral	Aspirin; Meprobamate	Discontinued

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 41Labeling · Standard review	Approved	Letter Label
Apr 28, 2021	Supplement 40Labeling · Standard review	Approved	Label Letter
Mar 22, 2006	Supplement 37Manufacturing · Standard review	Approved	None posted
May 19, 2003	Supplement 36Labeling · Standard review	Approved	None posted
Jan 27, 1988	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 22, 1988	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 8, 1987	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 12, 1986	Supplement 30Manufacturing · Standard review	Approved	None posted
Oct 29, 1985	Supplement 29Labeling	Approved	None posted
Dec 29, 1983	Supplement 28Labeling	Approved	None posted
Sep 19, 1983	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 6, 1981	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 15, 1978	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 15, 1978	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 15, 1978	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 20, 1978	Supplement 20Labeling	Approved	None posted
Apr 22, 1975	Supplement 5Labeling	Approved	None posted
May 27, 1960	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 11702
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters