Methocarbamol

ANDA 84231, held by Puracap Pharm. Methocarbamol.

As of Nov 14, 2026, ANDA 84231 (Methocarbamol), held by Puracap Pharm, was first approved by FDA on Oct 22, 1974, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 22, 1974
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 22, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 30, 1989	Supplement 29Bioequivalence	Approved	None posted
Oct 22, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84231
Drugs@FDA: Overview at FDA
Company: PuraCap 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