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 one supplier. 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. One supplier is 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

Pharmacology for NDA: 016785

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 016785

Antineoplastic Agents

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	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:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 016785

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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