Migergot

ANDA 86557, held by Cosette. Caffeine; Ergotamine Tartrate.

As of Nov 15, 2026, ANDA 86557 (Migergot), held by Cosette, was first approved by FDA on Oct 4, 1983, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 4, 1983
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 4, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Migergot100MG;2MG · suppository;rectal	Caffeine; Ergotamine Tartrate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Nov 8, 2012	Supplement 16Labeling	Approved	None posted
Jun 18, 2012	Supplement 14Labeling	Approved	None posted
Aug 1, 2003	Supplement 12Labeling	Approved	None posted
Oct 19, 1999	Supplement 6Labeling	Approved	None posted
Mar 12, 1999	Supplement 5Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 4Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 3Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 1Manufacturing	Approved	None posted
Oct 4, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 86557
Drugs@FDA: Overview at FDA
Company: Cosette

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