NDA 219131, held by Almatica. Duloxetine Hydrochloride.
As of Nov 15, 2026, NDA 219131 (Duloxetine Hydrochloride), held by Almatica, was first approved by FDA on Feb 27, 2026, with 1 approved supplement and 0 published complete response letters.
Duloxetine Delayed-Release Capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Duloxetine HydrochlorideEQ 80MG BASE · capsule, delayed rel pellets;oral | Duloxetine Hydrochloride | RxReference drug |
| Duloxetine HydrochlorideEQ 90MG BASE · capsule, delayed rel pellets;oral | Duloxetine Hydrochloride | RxReference drug |
| Duloxetine HydrochlorideEQ 120MG BASE · capsule, delayed rel pellets;oral | Duloxetine Hydrochloride | RxReference drug |
| Aug 17, 2026 | Supplement 1Labeling · Standard review | Approved | |
| Feb 27, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
