Methocarbamol And Aspirin

ANDA 81145, held by Stevens J. Aspirin; Methocarbamol.

As of Nov 15, 2026, ANDA 81145 (Methocarbamol And Aspirin), held by Stevens J, was first approved by FDA on Jan 31, 1995, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1995
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 31, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol And Aspirin325MG;400MG · tablet;oral	Aspirin; Methocarbamol	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Apr 29, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Jan 31, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 81145
Drugs@FDA: Overview at FDA
Company: Stevens J

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