Details for New Drug Application (NDA): 020229
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NDA 020229 describes LEUSTATIN, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the LEUSTATIN profile page.
The generic ingredient in LEUSTATIN is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.
The generic ingredient in LEUSTATIN is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.
Summary for 020229
| Tradename: | LEUSTATIN |
| Applicant: | Janssen Pharms |
| Ingredient: | cladribine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020229
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 26, 1993 | TE: | RLD: | Yes | |||||
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