Zomig

NDA 20768, held by Ipr. Zolmitriptan.

As of Nov 13, 2026, NDA 20768 (Zomig), held by Ipr, was first approved by FDA on Nov 25, 1997, with 18 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1997
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Nov 16, 2004	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Medical Review
Nov 25, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Products

2 strengths and forms


Zomig2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Zolmitriptan	DiscontinuedReference drug
Zomig5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Zolmitriptan	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Dec 21, 2018	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 12, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 14, 2012	Supplement 19Labeling · Standard review	Approved	Letter Label
Sep 14, 2012	Supplement 21Labeling	Approved	Letter Label
Aug 11, 2010	Supplement 17Labeling · Standard review	Approved	Label Letter
Nov 16, 2004	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Medical Review
Jan 8, 2004	Supplement 13Labeling · Standard review	Approved	Letter
May 21, 2003	Supplement 11Labeling · Standard review	Approved	Letter
Oct 9, 2002	Supplement 10Labeling · Standard review	Approved	Review Letter
Jan 29, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Dec 18, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 12, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
May 1, 2000	Supplement 3Labeling · Standard review	Approved	None posted
Mar 9, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 14, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 29, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 16, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 21, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 25, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20768
Drugs@FDA: Overview at FDA
Company: IPR 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