Sumatriptan

Treats migraine with or without aura. ANDA 213465, held by Padagis Israel. Sumatriptan.

As of Nov 13, 2026, ANDA 213465 (Sumatriptan), held by Padagis Israel, was first approved by FDA on Sep 21, 2020, with 0 approved supplements and 0 published complete response letters.

First approved: Sep 21, 2020
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:

Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of Sumatriptan Nasal Spray have not been established for cluster headache.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Sep 21, 2020	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Sumatriptan20MG/SPRAY · spray;nasal	Sumatriptan	Rx
Sumatriptan5MG/SPRAY · spray;nasal	Sumatriptan	Rx

Identifiers

Application: ANDA 213465
Drugs@FDA: Overview at FDA
Company: Padagis Israel

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters