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Last Updated: January 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209347

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NDA 209347 describes GANZYK-RTU, which is a drug marketed by Exela Pharma 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 GANZYK-RTU profile page.

The generic ingredient in GANZYK-RTU is ganciclovir. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.
Summary for 209347
Tradename:GANZYK-RTU
Applicant:Exela Pharma
Ingredient:ganciclovir
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 209347
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 209347
Suppliers and Packaging for NDA: 209347
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANZYK-RTU ganciclovir SOLUTION;INTRAVENOUS 209347 NDA EXELA PHARMA SCIENCES, LLC 51754-2500 51754-2500-1 250 mL in 1 BAG (51754-2500-1)
GANZYK-RTU ganciclovir SOLUTION;INTRAVENOUS 209347 NDA EXELA PHARMA SCIENCES, LLC 51754-2500 51754-2500-3 10 BAG in 1 POUCH (51754-2500-3) > 250 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength500MG/250ML (2MG/ML)
Approval Date:Feb 17, 2017TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Sep 2, 2034Product Flag?YSubstance Flag?Delist Request?

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