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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206856

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NDA 206856 describes TRANYLCYPROMINE SULFATE, which is a drug marketed by Crossmedika Sa, Novitium Pharma, and Strides Pharma Intl, and is included in three NDAs. It is available from four suppliers. Additional details are available on the TRANYLCYPROMINE SULFATE profile page.

The generic ingredient in TRANYLCYPROMINE SULFATE is tranylcypromine sulfate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tranylcypromine sulfate profile page.

Summary for 206856

Tradename:	TRANYLCYPROMINE SULFATE
Applicant:	Novitium Pharma
Ingredient:	tranylcypromine sulfate
Patents:	0

Pharmacology for NDA: 206856

Mechanism of Action	Monoamine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for 206856

Anti-Anxiety Agents
Antidepressive Agents
Monoamine Oxidase Inhibitors

Suppliers and Packaging for NDA: 206856

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	206856	ANDA	Marlex Pharmaceuticals, Inc.	10135-739	10135-739-01	100 TABLET in 1 BOTTLE (10135-739-01)
TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	206856	ANDA	Novitium Pharma LLC	70954-538	70954-538-10	100 TABLET in 1 BOTTLE (70954-538-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Apr 17, 2018	TE:	AB	RLD:	No

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