Details for New Drug Application (NDA): 203415
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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: | 3 |
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: | ⤷ Sign Up | Patent Expiration: | Aug 13, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC). |
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