Details for New Drug Application (NDA): 201275
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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 201275
Tradename: | SUNITINIB MALATE |
Applicant: | Mylan |
Ingredient: | sunitinib malate |
Patents: | 0 |
Pharmacology for NDA: 201275
Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 201275
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 201275 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6678 | 0378-6678-28 | 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6678-28) |
SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 201275 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6679 | 0378-6679-28 | 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-6679-28) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 12.5MG BASE | ||||
Approval Date: | Dec 6, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Dec 6, 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: | Dec 6, 2021 | TE: | AB | RLD: | No |
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