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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 Luitpold Pharms Inc, Ranbaxy Labs Ltd, Fresenius Kabi Usa, and Eurohlth Intl Sarl, and is included in four NDAs. It is available from three suppliers. Additional details are available on the GANCICLOVIR profile page.

The generic ingredient in GANCICLOVIR is ganciclovir. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.

Summary for NDA: 090658

Fresenius Kabi Usa
ganciclovir sodium
Therapeutic Class:Antivirals

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 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 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

Summary 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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