Details for New Drug Application (NDA): 207495
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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 207495
Tradename: | IMATINIB MESYLATE |
Applicant: | Amneal Pharms |
Ingredient: | imatinib mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207495
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 207495 | ANDA | Amneal Pharmaceuticals LLC | 65162-794 | 65162-794-03 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-794-03) |
IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 207495 | ANDA | Amneal Pharmaceuticals LLC | 65162-794 | 65162-794-09 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-794-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Feb 8, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Feb 8, 2019 | TE: | RLD: | No |
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