tranylcypromine sulfate

FDA Drug Profile — TRANYLCYPROMINE SULFATE, Tranylcypromine Sulfate, PARNATE

Drug Details

Generic Name
tranylcypromine sulfate
Brand Names
TRANYLCYPROMINE SULFATE, Tranylcypromine Sulfate, PARNATE
Application Number
ANDA040640
Sponsor
Strides Pharma Science Limited
NDC Codes
3
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
TRANYLCYPROMINE SULFATE

Indications and Usage

1 INDICATIONS AND USAGE Tranylcypromine Sulfate is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine Sulfate is 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 [see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)] . Tranylcypromine Sulfate is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants (1) Tranylcypromine Sulfate is 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 (1, 4, 5, 7)