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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076457

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NDA 076457 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 076457
Tradename:GANCICLOVIR
Applicant:Ranbaxy Labs Ltd
Ingredient:ganciclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 076457
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 076457
Suppliers and Packaging for NDA: 076457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANCICLOVIR ganciclovir CAPSULE;ORAL 076457 ANDA Ranbaxy Pharmaceuticals Inc. 63304-636 E 63304-636-60
GANCICLOVIR ganciclovir CAPSULE;ORAL 076457 ANDA Ranbaxy Pharmaceuticals Inc. 63304-636 E 63304-636-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Jun 27, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG
Approval Date:Jun 27, 2003TE:RLD:No

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