Details for New Drug Application (NDA): 213914
NDA 213914 describes SUNITINIB MALATE, which is a drug marketed by Dr Reddys, Eugia Pharma, Fosun Wanbang, MSN, Mylan, Natco Pharma, Sun Pharm, and Teva Pharms Usa, and is included in eight 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 is one drug master file entry for this compound. Nine 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
Summary for 213914
| Tradename: | SUNITINIB MALATE |
| Applicant: | Sun Pharm |
| Ingredient: | sunitinib malate |
| Patents: | 0 |
Pharmacology for NDA: 213914
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 213914
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 213914 | ANDA | Sun Pharmaceutical Industries Inc. | 63304-091 | 63304-091-27 | 28 CAPSULE in 1 BOTTLE (63304-091-27) |
| SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 213914 | ANDA | Sun Pharmaceutical Industries Inc. | 63304-091 | 63304-091-86 | 4 BLISTER PACK in 1 BOX (63304-091-86) / 7 CAPSULE in 1 BLISTER PACK (63304-091-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 12.5MG BASE | ||||
| Approval Date: | Aug 16, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Aug 16, 2021 | 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 16, 2021 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
