Details for New Drug Application (NDA): 214410
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NDA 214410 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 214410
| Tradename: | XOFLUZA |
| Applicant: | Genentech Inc |
| Ingredient: | baloxavir marboxil |
| Patents: | 9 |
Pharmacology for NDA: 214410
| Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
Suppliers and Packaging for NDA: 214410
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410 | NDA | Genentech, Inc. | 50242-583 | 50242-583-01 | 1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS |
| XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410 | NDA | Genentech, Inc. | 50242-599 | 50242-599-01 | 1 PACKET in 1 CARTON (50242-599-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2MG/ML | ||||
| Approval Date: | Nov 23, 2020 | 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: | 10,392,406 | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 10,633,397 | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA | ||||||||
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