Details for New Drug Application (NDA): 218711
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NDA 218711 describes BEIZRAY, which is a drug marketed by Zhuhai and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the BEIZRAY profile page.
The generic ingredient in BEIZRAY is docetaxel. There are forty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
The generic ingredient in BEIZRAY is docetaxel. There are forty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Pharmacology for NDA: 218711
| Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 218711
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BEIZRAY | docetaxel | SOLUTION;INTRAVENOUS | 218711 | NDA | Zydus Pharmaceuticals USA Inc. | 70710-2091 | 70710-2091-3 | 1 KIT in 1 KIT (70710-2091-3) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4) |
| BEIZRAY | docetaxel | SOLUTION;INTRAVENOUS | 218711 | NDA | Zydus Pharmaceuticals USA Inc. | 70710-2093 | 70710-2093-4 | 1 KIT in 1 KIT (70710-2093-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 80MG/4ML (20MG/ML) | ||||
| Approval Date: | Oct 23, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 16, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF BREAST CANCER | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 16, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF GASTRIC ADENOCARCINOMA | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 16, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HEAD AND NECK CANCER | ||||||||
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