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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076222


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NDA 076222 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hikma, Par Sterile Products, Pharmascience Inc, Slate Run Pharma, and Steriscience, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the GANCICLOVIR SODIUM profile page.

The generic ingredient in GANCICLOVIR SODIUM is ganciclovir sodium. There are twenty-seven 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 076222
Tradename:GANCICLOVIR SODIUM
Applicant:Hikma
Ingredient:ganciclovir sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076222
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 076222
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 076222 ANDA Hikma Pharmaceuticals USA Inc. 0143-9299 0143-9299-10 10 VIAL in 1 BOX (0143-9299-10) / 10 mL in 1 VIAL (0143-9299-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jul 16, 2003TE:APRLD:No

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