Details for New Drug Application (NDA): 203415
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NDA 203415 describes XTANDI, which is a drug marketed by Astellas and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XTANDI profile page.
The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.
The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.
Summary for 203415
| Tradename: | XTANDI |
| Applicant: | Astellas |
| Ingredient: | enzalutamide |
| Patents: | 4 |
Suppliers and Packaging for NDA: 203415
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XTANDI | enzalutamide | CAPSULE;ORAL | 203415 | NDA | Astellas Pharma US, Inc. | 0469-0125 | 0469-0125-99 | 1 BOTTLE in 1 CARTON (0469-0125-99) / 120 CAPSULE in 1 BOTTLE |
| XTANDI | enzalutamide | CAPSULE;ORAL | 203415 | NDA | Astellas Pharma US, Inc. | 0469-1125 | 0469-1125-56 | 56 CAPSULE in 1 BLISTER PACK (0469-1125-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Aug 31, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 17, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE AT HIGH RISK FOR METASTASIS | ||||||||
| Patent: | 12,161,628 | Patent Expiration: | Feb 23, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER TO WHOM RIFAMPIN IS ADMINISTERED WITH THE CO-ADMINISTRATION OF A DAILY DOSE OF 240 MG ENZALUTAMIDE | ||||||||
| Patent: | 12,161,628 | Patent Expiration: | Feb 23, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER TO WHOM RIFAMPIN IS ADMINISTERED WITH THE CO-ADMINISTRATION OF A DAILY DOSE OF 240 MG ENZALUTAMIDE | ||||||||
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