Details for New Drug Application (NDA): 206547
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NDA 206547 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 nineteen 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-one 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-one suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 206547
| Tradename: | IMATINIB MESYLATE |
| Applicant: | Dr Reddys |
| Ingredient: | imatinib mesylate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206547
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 206547 | ANDA | Dr.Reddy's Laboratories Inc | 43598-344 | 43598-344-10 | 1000 TABLET in 1 CONTAINER (43598-344-10) |
| IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 206547 | ANDA | Dr.Reddy's Laboratories Inc | 43598-344 | 43598-344-30 | 30 TABLET in 1 CONTAINER (43598-344-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Aug 13, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Aug 13, 2018 | TE: | AB | RLD: | No | ||||
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