Details for New Drug Application (NDA): 218012
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NDA 218012 describes SUNITINIB MALATE, which is a drug marketed by Dr Reddys, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, and Wanbang Biopharms, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the SUNITINIB MALATE profile page.
The generic ingredient in SUNITINIB MALATE is sunitinib malate. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
The generic ingredient in SUNITINIB MALATE is sunitinib malate. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
Summary for 218012
| Tradename: | SUNITINIB MALATE |
| Applicant: | Wanbang Biopharms |
| Ingredient: | sunitinib malate |
| Patents: | 0 |
Pharmacology for NDA: 218012
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 218012
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 218012 | ANDA | Novugen Pharma (USA) LLC. | 82293-014 | 82293-014-10 | 28 CAPSULE in 1 BOTTLE (82293-014-10) |
| SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 218012 | ANDA | Novugen Pharma (USA) LLC. | 82293-015 | 82293-015-10 | 28 CAPSULE in 1 BOTTLE (82293-015-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 12.5MG BASE | ||||
| Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 37.5MG BASE | ||||
| Approval Date: | Aug 21, 2023 | TE: | AB | RLD: | No | ||||
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