Details for New Drug Application (NDA): 209567
✉ Email this page to a colleague
The generic ingredient in SORAFENIB TOSYLATE is sorafenib tosylate. There are thirteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.
Summary for 209567
Tradename: | SORAFENIB TOSYLATE |
Applicant: | Teva Pharms Usa Inc |
Ingredient: | sorafenib tosylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209567
Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 209567
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 209567 | ANDA | Teva Pharmaceuticals, Inc. | 0480-5425 | 0480-5425-89 | 120 TABLET, FILM COATED in 1 BOTTLE (0480-5425-89) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | Nov 12, 2020 | TE: | AB | RLD: | No |
Complete Access Available with Subscription