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Last Updated: November 4, 2024

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-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 EffectMicrotubule 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:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/2ML (10MG/ML)
Approval Date:Nov 22, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2036Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength80MG/8ML (10MG/ML)
Approval Date:Nov 22, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2036Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength160MG/16ML (10MG/ML)
Approval Date:Nov 22, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2036Product Flag?YSubstance Flag?Delist Request?

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