ANDA 207393, held by Lupin Ltd. Diclofenac.
As of Nov 15, 2026, ANDA 207393 (Diclofenac), held by Lupin Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 2, 2016 | Original application | Tentative approval | None posted |
| Diclofenac18MG · capsule;oral | Diclofenac | None (tentative approval) |
| Diclofenac35MG · capsule;oral | Diclofenac | None (tentative approval) |
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
