Naratriptan

ANDA 91373, held by Apotex Corp. Naratriptan Hydrochloride.

As of Nov 15, 2026, ANDA 91373 (Naratriptan), held by Apotex Corp, was first approved by FDA on Apr 22, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2011
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
Apr 22, 2011	Original application	Approved	None posted

Products

2 strengths and forms


NaratriptanEQ 1MG BASE · tablet;oral	Naratriptan Hydrochloride	Discontinued
NaratriptanEQ 2.5MG BASE · tablet;oral	Naratriptan Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 14, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 30, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Apr 22, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91373
Drugs@FDA: Overview at FDA
Company: Apotex

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