Details for New Drug Application (NDA): 215813
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The generic ingredient in DOCIVYX is docetaxel. There are forty-one drug master file entries for this compound. Twenty-one 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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