ANDA 219639, held by Cmp Dev LLC. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 219639 (Amitriptyline Hydrochloride), held by Cmp Dev LLC, was first approved by FDA on Nov 5, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride40MG/ML ยท concentrate;oral | Amitriptyline 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
