Details for New Drug Application (NDA): 215813
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NDA 215813 describes DOCIVYX, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the DOCIVYX profile page.
The generic ingredient in DOCIVYX is docetaxel. There are forty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
The generic ingredient in DOCIVYX is docetaxel. There are forty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 215813
| Tradename: | DOCIVYX |
| Applicant: | Avyxa Holdings |
| Ingredient: | docetaxel |
| Patents: | 1 |
Pharmacology for NDA: 215813
| Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 215813
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOCIVYX | docetaxel | SOLUTION;INTRAVENOUS | 215813 | NDA | Avyxa Pharma, LLC | 83831-101 | 83831-101-02 | 1 VIAL, GLASS in 1 CARTON (83831-101-02) / 2 mL in 1 VIAL, GLASS |
| DOCIVYX | docetaxel | SOLUTION;INTRAVENOUS | 215813 | NDA | Avyxa Pharma, LLC | 83831-102 | 83831-102-08 | 1 VIAL, GLASS in 1 CARTON (83831-102-08) / 8 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/2ML (10MG/ML) | ||||
| Approval Date: | Nov 22, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 80MG/8ML (10MG/ML) | ||||
| Approval Date: | Nov 22, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 160MG/16ML (10MG/ML) | ||||
| Approval Date: | Nov 22, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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