Details for New Drug Application (NDA): 021588
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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 021588
Tradename: | GLEEVEC |
Applicant: | Novartis |
Ingredient: | imatinib mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021588
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588 | NDA | Novartis Pharmaceuticals Corporation | 0078-0401 | 0078-0401-34 | 90 TABLET in 1 BOTTLE (0078-0401-34) |
GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588 | NDA | Novartis Pharmaceuticals Corporation | 0078-0649 | 0078-0649-13 | 3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Apr 18, 2003 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Apr 18, 2003 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021588
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-002 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-001 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-002 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | GLEEVEC | imatinib mesylate | TABLET;ORAL | 021588-001 | Apr 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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