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Details for New Drug Application (NDA): 200181

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NDA 200181 describes PHENELZINE SULFATE, which is a drug marketed by Novel Labs Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the PHENELZINE SULFATE profile page.

The generic ingredient in PHENELZINE SULFATE is phenelzine sulfate. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phenelzine sulfate profile page.

Summary for NDA: 200181

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 200181

Mechanism of ActionMonoamine Oxidase Inhibitors

Suppliers and Packaging for NDA: 200181

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
phenelzine sulfate
TABLET;ORAL 200181 ANDA Novel Laboratories, Inc. 40032-360 40032-360-21 60 TABLET in 1 BOTTLE (40032-360-21)
phenelzine sulfate
TABLET;ORAL 200181 ANDA GAVIS Pharmaceuticals, LLC 43386-360 43386-360-21 60 TABLET in 1 BOTTLE (43386-360-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Dec 8, 2010TE:ABRLD:No

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