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Generated: September 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209347

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NDA 209347 describes GANCICLOVIR, which is a drug marketed by Ranbaxy Labs Ltd, Fresenius Kabi Usa, Luitpold, Mylan Labs Ltd, Par Sterile Products, Exela Pharma Scs Llc, Pharmascience Inc, and West-ward Pharms Int, and is included in eight NDAs. It is available from five suppliers. There is one patent protecting this drug. Additional details are available on the GANCICLOVIR profile page.

The generic ingredient in GANCICLOVIR is ganciclovir sodium. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 209347
Applicant:Exela Pharma Scs Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 209347
Ingredient-typeNucleoside Analog
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
GANCICLOVIR ganciclovir SOLUTION;IV (INFUSION) 209347 NDA EXELA PHARMA SCIENCES, LLC 51754-2500 51754-2500-1 250 mL in 1 BAG (51754-2500-1)
GANCICLOVIR ganciclovir SOLUTION;IV (INFUSION) 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;IV (INFUSION)Strength500MG/250ML (2MG/ML)
Approval Date:Feb 17, 2017TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 2, 2034Product Flag?YSubstance Flag?Delist Request?

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