Micrainin

ANDA 84978, held by Medpointe Pharm Hlc. Aspirin; Meprobamate.

As of Nov 15, 2026, ANDA 84978 (Micrainin), held by Medpointe Pharm Hlc, was first approved by FDA on Jul 31, 1978, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1978
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
Jul 31, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Micrainin325MG;200MG · tablet;oral	Aspirin; Meprobamate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 18, 1992	Supplement 11Manufacturing	Approved	None posted
Feb 20, 1990	Supplement 10Labeling	Approved	None posted
Jul 31, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 84978
Drugs@FDA: Overview at FDA
Company: Medpointe Pharmaceuticals

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