Relieves symptoms of depression. ANDA 202446, held by Accord Hlthcare. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 202446 (Amitriptyline Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Jun 4, 2014, 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 |
|---|---|---|---|
| Jun 4, 2014 | Original application | Approved | None posted |
| Amitriptyline Hydrochloride10MG · tablet;oral | Amitriptyline Hydrochloride | Rx |
| Amitriptyline Hydrochloride25MG · 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 24, 2025 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 20, 2025 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 25, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 4, 2014 | 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
