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Serving leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
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Federal Trade Commission
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Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209347

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NDA 209347 describes GANCICLOVIR, which is a drug marketed by Luitpold Pharms Inc, Exela Pharma Scs Llc, Par Sterile Products, Ranbaxy Labs Ltd, Fresenius Kabi Usa, and West-ward Pharms Int, and is included in six 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 . There are twenty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.

Summary for NDA: 209347

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 209347

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength500MG/250ML (2MG/ML)
Approval Date:Feb 17, 2017TE:RLD:Yes
Patent:► SubscribePatent Expiration:Sep 2, 2034Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Novartis
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