Methocarbamol

ANDA 84616, held by Aiping Pharm Inc. Methocarbamol.

As of Nov 14, 2026, ANDA 84616 (Methocarbamol), held by Aiping Pharm Inc, was first approved by FDA on Dec 19, 1975, with 33 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1975
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Dec 19, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 34 submissions, including labeling and manufacturing supplements


Apr 28, 2008	Supplement 85Labeling	Approved	None posted
Apr 19, 2002	Supplement 76Manufacturing	Approved	None posted
Dec 10, 2001	Supplement 74Manufacturing	Approved	None posted
May 9, 2001	Supplement 75Manufacturing	Approved	None posted
Oct 7, 1999	Supplement 73Manufacturing	Approved	None posted
May 5, 1999	Supplement 72Manufacturing	Approved	None posted
Sep 28, 1998	Supplement 71Manufacturing	Approved	None posted
Sep 28, 1998	Supplement 70Manufacturing	Approved	None posted
Sep 28, 1998	Supplement 69Manufacturing	Approved	None posted
Aug 11, 1997	Supplement 68Manufacturing	Approved	None posted
Sep 22, 1995	Supplement 67Manufacturing	Approved	None posted
Mar 7, 1995	Supplement 66Manufacturing	Approved	None posted
Jul 23, 1990	Supplement 65Labeling	Approved	None posted
Mar 21, 1989	Supplement 63Labeling	Approved	None posted
Feb 9, 1989	Supplement 62Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 61Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 60Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 59Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 58Manufacturing	Approved	None posted
Mar 5, 1987	Supplement 57Manufacturing	Approved	None posted
Aug 16, 1985	Supplement 56Manufacturing	Approved	None posted
Apr 24, 1985	Supplement 54Manufacturing	Approved	None posted
Sep 19, 1984	Supplement 51Manufacturing	Approved	None posted
Jul 17, 1984	Supplement 53Manufacturing	Approved	None posted
Jul 17, 1984	Supplement 52Manufacturing	Approved	None posted
Feb 14, 1984	Supplement 41Manufacturing	Approved	None posted
Jun 17, 1983	Supplement 50Manufacturing	Approved	None posted
Jun 17, 1983	Supplement 49Manufacturing	Approved	None posted
Feb 23, 1983	Supplement 48Manufacturing	Approved	None posted
Jul 28, 1982	Supplement 47Manufacturing	Approved	None posted
Apr 6, 1982	Supplement 45Manufacturing	Approved	None posted
Feb 4, 1982	Supplement 44Manufacturing	Approved	None posted
Feb 4, 1982	Supplement 42Manufacturing	Approved	None posted
Dec 19, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84616
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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