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Chinese Patent Office
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Generated: February 25, 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 Pharms Inc, 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 three 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-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 209347
Applicant:Exela Pharma Scs Llc
Therapeutic Class:Antivirals
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 N 51754-2500-1
GANCICLOVIR ganciclovir SOLUTION;IV (INFUSION) 209347 NDA EXELA PHARMA SCIENCES, LLC 51754-2500 N 51754-2500-3

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:➤ Sign UpPatent Expiration:Sep 2, 2034Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

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