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Boehringer Ingelheim

Last Updated: December 7, 2023

Details for New Drug Application (NDA): 011909

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NDA 011909 describes NARDIL, which is a drug marketed by Parke Davis and is included in one NDA. It is available from two suppliers. Additional details are available on the NARDIL profile page.

The generic ingredient in NARDIL is phenelzine sulfate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the phenelzine sulfate profile page.
Summary for 011909
Applicant:Parke Davis
Ingredient:phenelzine sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 011909
Mechanism of ActionMonoamine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 011909
Suppliers and Packaging for NDA: 011909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NARDIL phenelzine sulfate TABLET;ORAL 011909 NDA Parke-Davis Div of Pfizer Inc 0071-0350 0071-0350-60 60 TABLET, FILM COATED in 1 BOTTLE (0071-0350-60)
NARDIL phenelzine sulfate TABLET;ORAL 011909 NDA AUTHORIZED GENERIC Greenstone LLC 59762-0119 59762-0119-1 60 TABLET, FILM COATED in 1 BOTTLE (59762-0119-1)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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