Details for New Drug Application (NDA): 207495
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NDA 207495 describes IMATINIB MESYLATE, which is a drug marketed by Amneal Pharms, Apotex, Chartwell Rx, Cspc Ouyi, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Hikma, Mylan, Natco Pharma Ltd, Novitium Pharma, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in sixteen NDAs. It is available from twenty suppliers. Additional details are available on the IMATINIB MESYLATE profile page.
The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-two 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 |
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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