Wigraine

ANDA 86562, held by Organon USA Inc. Caffeine; Ergotamine Tartrate.

As of Nov 15, 2026, ANDA 86562 (Wigraine), held by Organon USA Inc, was first approved by FDA on Nov 5, 1980, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 5, 1980
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Nov 5, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Wigraine100MG;1MG · tablet;oral	Caffeine; Ergotamine Tartrate	Discontinued

All 14 submissions, including labeling and manufacturing supplements


May 2, 2000	Supplement 17Manufacturing	Approved	None posted
Oct 14, 1999	Supplement 16Manufacturing	Approved	None posted
Oct 21, 1998	Supplement 15Manufacturing	Approved	None posted
Jun 12, 1998	Supplement 10Labeling	Approved	None posted
Mar 7, 1994	Supplement 11Manufacturing	Approved	None posted
Mar 7, 1994	Supplement 14Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 12Labeling	Approved	None posted
Aug 31, 1993	Supplement 13Labeling	Approved	None posted
Jan 19, 1989	Supplement 9Manufacturing	Approved	None posted
Jul 6, 1987	Supplement 8Manufacturing	Approved	None posted
May 14, 1985	Supplement 7Manufacturing	Approved	None posted
Mar 29, 1983	Supplement 3Manufacturing	Approved	None posted
Mar 29, 1983	Supplement 4Manufacturing	Approved	None posted
Nov 5, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 86562
Drugs@FDA: Overview at FDA
Company: Organon USA

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