Naratriptan

ANDA 202431, held by Aurobindo Pharma USA. Naratriptan Hydrochloride.

As of Nov 15, 2026, ANDA 202431 (Naratriptan), held by Aurobindo Pharma USA, was first approved by FDA on May 31, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: May 31, 2012
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
May 31, 2012	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


Oct 20, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Sep 16, 2015	Supplement 1Labeling · Standard review	Approved	None posted
May 31, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202431
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma 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