Details for New Drug Application (NDA): 210951
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NDA 210951 describes ERLEADA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ERLEADA profile page.
The generic ingredient in ERLEADA is apalutamide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
The generic ingredient in ERLEADA is apalutamide. There is one drug master file entry for this compound. 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: | 14 |
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: | ⤷ Start Trial | 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 | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 23, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT IN COMBINATION WITH ORCHIECTOMY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 14, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) IN A MALE HUMAN WHO HAS SEVERE HEPATIC IMPAIRMENT | ||||||||
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