Procarbazine hydrochloride - Generic Drug Details

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What are the generic drug sources for procarbazine hydrochloride and what is the scope of freedom to operate?

Procarbazine hydrochloride is the generic ingredient in one branded drug marketed by Leadiant Biosci Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for procarbazine hydrochloride. One supplier is listed for this compound.

Summary for procarbazine hydrochloride

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	88
Patent Applications:	7,158
What excipients (inactive ingredients) are in procarbazine hydrochloride?	procarbazine hydrochloride excipients list
DailyMed Link:	procarbazine hydrochloride at DailyMed

Recent Clinical Trials for procarbazine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hospital Civil de Guadalajara	Phase 4
University of Guadalajara	Phase 4
Merck Sharp & Dohme Corp.	Phase 2

See all procarbazine hydrochloride clinical trials

Pharmacology for procarbazine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for procarbazine hydrochloride

Antineoplastic Agents

Anatomical Therapeutic Chemical (ATC) Classes for procarbazine hydrochloride

L01XB	Methylhydrazines
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for procarbazine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for procarbazine hydrochloride

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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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