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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 204950

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NDA 204950 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly Pharm, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int, 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. Seven suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 204950
Applicant:Par Sterile Products
Ingredient:ganciclovir sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 204950
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 204950
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204950 ANDA Par Pharmaceutical, Inc. 42023-173 42023-173-25 25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) > 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 6, 2016TE:APRLD:No

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