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.
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
| Tradename: | LEUKERAN |
| Applicant: | Waylis Therap |
| Ingredient: | chlorambucil |
| Patents: | 0 |
Pharmacology for NDA: 010669
| Mechanism of Action | Alkylating 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: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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