Details for New Drug Application (NDA): 210951
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The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
Summary for 210951
Tradename: | ERLEADA |
Applicant: | Janssen Biotech |
Ingredient: | apalutamide |
Patents: | 11 |
Suppliers and Packaging for NDA: 210951
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-600 | 59676-600-12 | 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12) |
ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-600 | 59676-600-56 | 2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Feb 14, 2018 | TE: | AB | RLD: | Yes | ||||
Patent: | 10,052,314 | Patent Expiration: | Sep 23, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patented Use: | TREATMENT IN COMBINATION WITH A GNRH AGONIST OF HIGH RISK NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC) | ||||||||
Patent: | 10,052,314 | Patent Expiration: | Sep 23, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patented Use: | TREATMENT IN COMBINATION WITH A GNRH AGONIST OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC) | ||||||||
Patent: | 10,702,508 | Patent Expiration: | Apr 30, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT IN COMBINATION WITH ANDROGEN DEPRIVATION THERAPY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) THAT IMPROVES METASTASIS FREE SURVIVAL |
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