Details for New Drug Application (NDA): 216073
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NDA 216073 describes SORAFENIB TOSYLATE, which is a drug marketed by Dr Reddys, Mylan, Teva Pharms Usa Inc, Torrent, and Yabao Pharm, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the SORAFENIB TOSYLATE profile page.
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.
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 216073
| Tradename: | SORAFENIB TOSYLATE |
| Applicant: | Dr Reddys |
| Ingredient: | sorafenib tosylate |
| Patents: | 0 |
Pharmacology for NDA: 216073
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 216073
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 216073 | ANDA | Dr.Reddys Laboratories Inc | 43598-458 | 43598-458-04 | 120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04) |
| SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 216073 | ANDA | Dr.Reddys Laboratories Inc | 43598-458 | 43598-458-36 | 360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jun 7, 2022 | TE: | AB | RLD: | No | ||||
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