ANDA 207874, held by Ipca Labs Ltd. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 207874 (Bupropion Hydrochloride), held by Ipca Labs Ltd, was first approved by FDA on May 2, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 2025 | Original application | Approved | None posted |
| Bupropion Hydrochloride100MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride200MG · tablet, extended release;oral | Bupropion Hydrochloride | 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
