Treats major depressive disorder (MDD). ANDA 213503, held by Crossmedika SA. Tranylcypromine Sulfate.
As of Nov 15, 2026, ANDA 213503 (Tranylcypromine Sulfate), held by Crossmedika SA, was first approved by FDA on Jun 27, 2022, with 0 approved supplements and 0 published complete response letters.
Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranylcypromine SulfateEQ 10MG BASE · tablet;oral | Tranylcypromine Sulfate | 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
