Relieves symptoms of depression. ANDA 212654, held by Aiping Pharm Inc. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 212654 (Amitriptyline Hydrochloride), held by Aiping Pharm Inc, was first approved by FDA on Apr 7, 2020, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2020 | Original application | Approved | None posted |
| Amitriptyline Hydrochloride25MG · tablet;oral | Amitriptyline Hydrochloride | Rx |
| Amitriptyline Hydrochloride10MG · tablet;oral | Amitriptyline Hydrochloride | Rx |
| Amitriptyline Hydrochloride50MG · tablet;oral | Amitriptyline Hydrochloride | Rx |
| Amitriptyline Hydrochloride75MG · tablet;oral | Amitriptyline Hydrochloride | Rx |
| Amitriptyline Hydrochloride100MG · tablet;oral | Amitriptyline Hydrochloride | Rx |
| Amitriptyline Hydrochloride150MG · tablet;oral | Amitriptyline Hydrochloride | Rx |
| Jun 27, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 27, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 29, 2021 | Supplement 1Manufacturing | Approved | None posted |
| Apr 7, 2020 | 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
