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Generated: April 21, 2019

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Details for New Drug Application (NDA): 204950

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NDA 204950 describes GANCICLOVIR, which is a drug marketed by Ranbaxy Labs Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Luitpold, Mylan Labs Ltd, Par Sterile Products, Exela Pharma Scs Llc, Pharmascience Inc, and West-ward Pharms Int, and is included in nine NDAs. It is available from six 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-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
Tradename:GANCICLOVIR
Applicant:Par Sterile Products
Ingredient:ganciclovir sodium
Patents:0
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 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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