Details for New Drug Application (NDA): 209050
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The generic ingredient in SORAFENIB TOSYLATE is sorafenib tosylate. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.
Summary for 209050
Tradename: | SORAFENIB TOSYLATE |
Applicant: | Yabao Pharm |
Ingredient: | sorafenib tosylate |
Patents: | 0 |
Pharmacology for NDA: 209050
Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 209050
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 209050 | ANDA | TWi Pharmaceuticals USA, Inc. | 24979-715 | 24979-715-04 | 60 TABLET, FILM COATED in 1 BOTTLE (24979-715-04) |
SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 209050 | ANDA | TWi Pharmaceuticals USA, Inc. | 24979-715 | 24979-715-44 | 120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | Nov 9, 2022 | TE: | AB | RLD: | No |
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