Naratriptan

Treats migraine attacks with or without aura. ANDA 90381, held by Hikma. Naratriptan Hydrochloride.

As of Nov 15, 2026, ANDA 90381 (Naratriptan), held by Hikma, 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

What It's For

From the FDA-approved label (Indications and Usage)

Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use:

Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks.
Naratriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of naratriptan have not been established for cluster headache. Naratriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.

Full prescribing information on DailyMed ↗

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	Rx
NaratriptanEQ 2.5MG BASE · tablet;oral	Naratriptan Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Apr 23, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Sep 14, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Oct 11, 2011	Supplement 1Labeling	Approved	None posted
Jul 7, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 90381
Drugs@FDA: Overview at FDA
Company: Hikma

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