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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 219920


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NDA 219920 describes AVGEMSI, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the AVGEMSI profile page.

The generic ingredient in AVGEMSI is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 219920
Tradename:AVGEMSI
Applicant:Avyxa Holdings
Ingredient:gemcitabine hydrochloride
Patents:0
Pharmacology for NDA: 219920
Mechanism of ActionNucleic Acid Synthesis Inhibitors
Suppliers and Packaging for NDA: 219920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVGEMSI gemcitabine hydrochloride SOLUTION;INTRAVENOUS 219920 NDA Avyxa Pharma, LLC 83831-123 83831-123-01 1 VIAL, MULTI-DOSE in 1 CARTON (83831-123-01) / 26.3 mL in 1 VIAL, MULTI-DOSE
AVGEMSI gemcitabine hydrochloride SOLUTION;INTRAVENOUS 219920 NDA Avyxa Pharma, LLC 83831-124 83831-124-01 1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)
Approval Date:Jun 27, 2025TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)
Approval Date:Jun 27, 2025TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)
Approval Date:Jun 27, 2025TE:RLD:Yes

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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