Details for New Drug Application (NDA): 217095
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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 217095
Tradename: | SORAFENIB TOSYLATE |
Applicant: | Torrent |
Ingredient: | sorafenib tosylate |
Patents: | 0 |
Pharmacology for NDA: 217095
Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 217095
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 217095 | ANDA | Torrent Pharmaceuticals Limited | 13668-682 | 13668-682-12 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12) |
SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 217095 | ANDA | Torrent Pharmaceuticals Limited | 13668-682 | 13668-682-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | Apr 12, 2023 | TE: | AB | RLD: | No |
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