Diclofenac Potassium

Treats migraine attacks with or without aura. ANDA 215375, held by Annora Pharma. Diclofenac Potassium.

As of Nov 15, 2026, ANDA 215375 (Diclofenac Potassium), held by Annora Pharma, was first approved by FDA on Mar 4, 2022, with 0 approved supplements and 0 published complete response letters.

First approved: Mar 4, 2022
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use:

Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine.
The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Mar 4, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diclofenac Potassium50MG · for solution;oral	Diclofenac Potassium	Rx

Identifiers

Application: ANDA 215375
Drugs@FDA: Overview at FDA
Company: Annora Pharma

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