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Generated: November 13, 2018

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Details for New Drug Application (NDA): 016785

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NDA 016785 describes MATULANE, which is a drug marketed by Leadiant Biosci Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the MATULANE profile page.

The generic ingredient in MATULANE is procarbazine hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the procarbazine hydrochloride profile page.
Summary for 016785
Tradename:MATULANE
Applicant:Leadiant Biosci Inc
Ingredient:procarbazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016785
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 016785
Suppliers and Packaging for NDA: 016785
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MATULANE procarbazine hydrochloride CAPSULE;ORAL 016785 NDA Sigma-Tau Pharmaceuticals, Inc. 54482-053 54482-053-01 100 CAPSULE in 1 BOTTLE (54482-053-01)
MATULANE procarbazine hydrochloride CAPSULE;ORAL 016785 NDA Leadiant Biosciences, Inc. 54482-054 54482-054-01 100 CAPSULE in 1 BOTTLE (54482-054-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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