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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
US Department of Justice

Generated: June 21, 2018

DrugPatentWatch Database Preview

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 four 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 200181
Applicant:Novel Labs Inc
Ingredient:phenelzine sulfate
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 200181
Mechanism of ActionMonoamine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 200181
Suppliers and Packaging for NDA: 200181
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENELZINE SULFATE phenelzine sulfate TABLET;ORAL 200181 ANDA Novel Laboratories, Inc. 40032-360 N 40032-360-21
PHENELZINE SULFATE phenelzine sulfate TABLET;ORAL 200181 ANDA Lupin Pharmaceuticals,Inc. 43386-360 N 43386-360-21

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Federal Trade Commission

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