Details for New Drug Application (NDA): 210854
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NDA 210854 describes XOFLUZA, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are ten patents protecting this drug. Additional details are available on the XOFLUZA profile page.
The generic ingredient in XOFLUZA is baloxavir marboxil. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.
The generic ingredient in XOFLUZA is baloxavir marboxil. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.
Summary for 210854
| Tradename: | XOFLUZA |
| Applicant: | Genentech Inc |
| Ingredient: | baloxavir marboxil |
| Patents: | 9 |
Pharmacology for NDA: 210854
| Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
Suppliers and Packaging for NDA: 210854
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860 | 50242-860-01 | 1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860 | 50242-860-86 | 1 BLISTER PACK in 1 CARTON (50242-860-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 24, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA | ||||||||
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