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Details for New Drug Application (NDA): 202570
NDA 202570 describes XALKORI, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the XALKORI profile page.
The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
Summary for 202570
| Tradename: | XALKORI |
| Applicant: | Pf Prism Cv |
| Ingredient: | crizotinib |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202570
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XALKORI | crizotinib | CAPSULE;ORAL | 202570 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-8140 | N | 0069-8140-20 |
| XALKORI | crizotinib | CAPSULE;ORAL | 202570 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-8141 | N | 0069-8141-20 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 26, 2011 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 14, 2018 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING REGARDING PREVIOUSLY UNTREATED ALK-POSITIVE METASTATIC NON SMALL CELL LUNG CANCER (NSCLC) | ||||||||
| Regulatory Exclusivity Expiration: | Aug 26, 2018 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Mar 11, 2023 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS-1 POSITIVE. | ||||||||
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