Details for New Drug Application (NDA): 218615
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NDA 218615 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 218615
| Tradename: | SUNITINIB MALATE |
| Applicant: | Eugia Pharma |
| Ingredient: | sunitinib malate |
| Patents: | 0 |
Pharmacology for NDA: 218615
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 218615
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 218615 | ANDA | Aurobindo Pharma Limited | 59651-464 | 59651-464-28 | 28 CAPSULE in 1 BOTTLE (59651-464-28) |
| SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 218615 | ANDA | Aurobindo Pharma Limited | 59651-464 | 59651-464-29 | 4 BLISTER PACK in 1 CARTON (59651-464-29) / 7 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 12.5MG BASE | ||||
| Approval Date: | Mar 14, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Mar 14, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 37.5MG BASE | ||||
| Approval Date: | Mar 14, 2024 | TE: | AB | RLD: | No | ||||
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