Relieves mild to moderate acute pain. ANDA 213875, held by Aurobindo Pharma Ltd. Diclofenac Potassium.
As of Nov 15, 2026, ANDA 213875 (Diclofenac Potassium), held by Aurobindo Pharma Ltd, was first approved by FDA on Oct 19, 2021, with 0 approved supplements and 0 published complete response letters.
Diclofenac potassium capsules are indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diclofenac Potassium25MG · capsule;oral | Diclofenac Potassium | Rx |
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
