Details for New Drug Application (NDA): 021335
✉ Email this page to a colleague
The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 021335
Tradename: | GLEEVEC |
Applicant: | Novartis |
Ingredient: | imatinib mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 021335
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 10, 2001 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 10, 2001 | TE: | RLD: | Yes |
Expired US Patents for NDA 021335
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-002 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-001 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-002 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-001 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-002 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | CAPSULE;ORAL | 021335-001 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription