Chlorambucil - Generic Drug Details

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What are the generic sources for chlorambucil and what is the scope of patent protection?

Chlorambucil is the generic ingredient in one branded drug marketed by Waylis Therap and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for chlorambucil. Two suppliers are listed for this compound.

Summary for chlorambucil

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	82
Patent Applications:	3,589
What excipients (inactive ingredients) are in chlorambucil?	chlorambucil excipients list
DailyMed Link:	chlorambucil at DailyMed

Recent Clinical Trials for chlorambucil

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

Sponsor	Phase
The Lymphoma Academic Research Organisation	Phase 3
X-act Cologne Clinical Research GmbH	N/A
Institute of Epidemiology and Medical Biometry, Ulm University	N/A

See all chlorambucil clinical trials

Pharmacology for chlorambucil

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for chlorambucil

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for chlorambucil

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for chlorambucil

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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
Waylis Therap	LEUKERAN	chlorambucil	TABLET;ORAL	010669-002	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

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