NDA 215133, held by Almatica. Sertraline Hydrochloride.
As of Nov 13, 2026, NDA 215133 (Sertraline Hydrochloride), held by Almatica, was first approved by FDA on Oct 4, 2021, with 2 approved supplements and 0 published complete response letters.
Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following: Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older Sertraline Hydrochloride (HCl) Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older
| Oct 4, 2021 | Original applicationNew dosage form · Standard review | Approved | |
| Oct 4, 2021 | Original applicationNew dosage form · Standard review | Approved |
| Sertraline HydrochlorideEQ 150MG BASE · capsule;oral | Sertraline Hydrochloride | RxReference drug |
| Sertraline HydrochlorideEQ 200MG BASE · capsule;oral | Sertraline Hydrochloride | RxReference drug |
| Oct 6, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Aug 18, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Oct 4, 2021 | Original applicationNew dosage form · Standard review | Approved | |
| Oct 4, 2021 | Original applicationNew dosage form · 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
