Relieves mild to moderate acute pain. ANDA 204648, held by Bionpharma. Diclofenac Potassium.
As of Nov 15, 2026, ANDA 204648 (Diclofenac Potassium), held by Bionpharma, was first approved by FDA on Feb 23, 2016, with 3 approved supplements and 0 published complete response letters.
Diclofenac potassium capsules are indicated for relief of mild to moderate acute pain in adult patients. Pediatric use information is approved for Assertio Therapeutics Inc's ZIPSOR (diclofenac potassium) Capsules. However, due to Assertio Therapeutics Inc's marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diclofenac Potassium25MG · capsule;oral | Diclofenac Potassium | Rx |
| Apr 23, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 23, 2025 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 2, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 23, 2016 | Original application | Approved | None posted |
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
