Treats primary dysmenorrhea for relief of mild to moderate pain for relief of the signs…. ANDA 215585, held by Ingenus Pharms LLC. Diclofenac Potassium.
As of Nov 15, 2026, ANDA 215585 (Diclofenac Potassium), held by Ingenus Pharms LLC, was first approved by FDA on Oct 8, 2021, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are indicated: for treatment of primary dysmenorrhea for relief of mild to moderate pain for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diclofenac Potassium50MG · tablet;oral | Diclofenac Potassium | Rx |
| Nov 21, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 13, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 8, 2021 | 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
