Naratriptan

ANDA 78751, held by Ani Pharms. Naratriptan Hydrochloride.

As of Nov 15, 2026, ANDA 78751 (Naratriptan), held by Ani Pharms, was first approved by FDA on Jul 7, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 7, 2010
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 7, 2010	Original application	Approved	Letter

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jul 15, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Apr 24, 2012	Supplement 2Labeling	Approved	None posted
Dec 30, 2010	Supplement 1Labeling	Approved	None posted
Jul 7, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 78751
Drugs@FDA: Overview at FDA
Company: ANI 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