Details for New Drug Application (NDA): 208302
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The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 208302
Tradename: | IMATINIB MESYLATE |
Applicant: | Shilpa |
Ingredient: | imatinib mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208302
Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208302
Suppliers and Packaging for NDA: 208302
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 208302 | ANDA | Areva Pharmaceuticals | 59923-723 | 59923-723-90 | 90 TABLET, COATED in 1 BOTTLE (59923-723-90) |
IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 208302 | ANDA | Areva Pharmaceuticals | 59923-724 | 59923-724-30 | 30 TABLET, COATED in 1 BOTTLE (59923-724-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Jan 17, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Jan 17, 2019 | TE: | AB | RLD: | No |
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