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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 010669

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NDA 010669 describes LEUKERAN, which is a drug marketed by Waylis Therap and is included in one NDA. It is available from two suppliers. Additional details are available on the LEUKERAN profile page.

The generic ingredient in LEUKERAN is chlorambucil. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorambucil profile page.
Summary for 010669
Applicant:Waylis Therap
Formulation / Manufacturing:see details
Pharmacology for NDA: 010669
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 010669
Suppliers and Packaging for NDA: 010669
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUKERAN chlorambucil TABLET;ORAL 010669 NDA Woodward Pharma Services LLC 69784-610 69784-610-25 25 TABLET, FILM COATED in 1 BOTTLE (69784-610-25)
LEUKERAN chlorambucil TABLET;ORAL 010669 NDA Waylis Therapeutics LLC 80725-610 80725-610-25 25 TABLET, FILM COATED in 1 BOTTLE (80725-610-25)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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