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Generated: September 26, 2018

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Details for New Drug Application (NDA): 090658

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NDA 090658 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 090658
Tradename:GANCICLOVIR
Applicant:Fresenius Kabi Usa
Ingredient:ganciclovir sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090658
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 090658
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANCICLOVIR ganciclovir sodium INJECTABLE;INJECTION 090658 ANDA Fresenius Kabi USA, LLC 63323-315 63323-315-94 25 VIAL in 1 TRAY (63323-315-94) > 10 mL in 1 VIAL
GANCICLOVIR ganciclovir sodium INJECTABLE;INJECTION 090658 ANDA Fresenius Kabi USA, LLC 63323-315 63323-315-10 25 VIAL in 1 TRAY (63323-315-10) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 21, 2010TE:APRLD:No

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