Details for New Drug Application (NDA): 217968
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NDA 217968 describes LAPATINIB DITOSYLATE, which is a drug marketed by Natco Pharma Ltd and Teva Pharms Usa Inc and is included in two NDAs. It is available from three suppliers. Additional details are available on the LAPATINIB DITOSYLATE profile page.
The generic ingredient in LAPATINIB DITOSYLATE is lapatinib ditosylate. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lapatinib ditosylate profile page.
The generic ingredient in LAPATINIB DITOSYLATE is lapatinib ditosylate. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lapatinib ditosylate profile page.
Summary for 217968
| Tradename: | LAPATINIB DITOSYLATE |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | lapatinib ditosylate |
| Patents: | 0 |
Pharmacology for NDA: 217968
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 217968
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAPATINIB DITOSYLATE | lapatinib ditosylate | TABLET;ORAL | 217968 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3237 | 0480-3237-51 | 150 TABLET, FILM COATED in 1 BOTTLE (0480-3237-51) |
| LAPATINIB DITOSYLATE | lapatinib ditosylate | TABLET;ORAL | 217968 | ANDA | AvKARE | 42291-035 | 42291-035-15 | 150 TABLET, FILM COATED in 1 BOTTLE (42291-035-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Aug 16, 2024 | TE: | AB | RLD: | No | ||||
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