Robaxisal

NDA 12281, held by Robins Ah. Aspirin; Methocarbamol.

As of Nov 13, 2026, NDA 12281 (Robaxisal), held by Robins Ah, was first approved by FDA on Apr 15, 1960, with 30 approved supplements and 0 published complete response letters.

First approved: Apr 15, 1960
Review: Standard
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Apr 15, 1960	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Robaxisal325MG;400MG · tablet;oral	Aspirin; Methocarbamol	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Feb 10, 2004	Supplement 52Labeling · Standard review	Approved	Letter
Feb 10, 2004	Supplement 51Labeling · Standard review	Approved	Letter
Feb 10, 2004	Supplement 50Labeling · Standard review	Approved	Letter
Apr 22, 1998	Supplement 49Manufacturing · Standard review	Approved	None posted
Oct 19, 1990	Supplement 46Manufacturing · Standard review	Approved	None posted
May 2, 1989	Supplement 42Manufacturing · Standard review	Approved	None posted
Jan 6, 1989	Supplement 45Manufacturing · Standard review	Approved	None posted
Jan 22, 1988	Supplement 43Manufacturing · Standard review	Approved	None posted
Jan 22, 1987	Supplement 44Manufacturing · Standard review	Approved	None posted
Jan 14, 1986	Supplement 41Labeling · Standard review	Approved	None posted
Aug 6, 1985	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 8, 1984	Supplement 40Manufacturing · Standard review	Approved	None posted
May 2, 1983	Supplement 37Manufacturing · Standard review	Approved	None posted
Apr 7, 1983	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 26, 1982	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 26, 1982	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 22, 1981	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 22, 1981	Supplement 31Manufacturing · Standard review	Approved	None posted
Dec 22, 1981	Supplement 30Manufacturing · Standard review	Approved	None posted
Oct 22, 1981	Supplement 27Manufacturing · Standard review	Approved	None posted
May 20, 1981	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 16, 1981	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 16, 1981	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 27, 1980	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 13, 1980	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 6, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 19, 1979	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 17, 1979	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 11, 1975	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 28, 1975	Supplement 5Labeling · Standard review	Approved	None posted
Apr 15, 1960	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12281
Drugs@FDA: Overview at FDA
Company: Robins Ah

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