Naratriptan

ANDA 91552, held by Sun Pharm Inds Ltd. Naratriptan Hydrochloride.

As of Nov 15, 2026, ANDA 91552 (Naratriptan), held by Sun Pharm Inds Ltd, was first approved by FDA on Feb 14, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 14, 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
Feb 14, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
NaratriptanEQ 2.5MG BASE · tablet;oral	Naratriptan Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 22, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Aug 30, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Feb 14, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91552
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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