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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212001


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NDA 212001 describes GANCICLOVIR SODIUM, which is a drug marketed by Custopharm Inc, Fresenius Kabi Usa, Hainan Poly Pharm, Luitpold, 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 212001
Tradename:GANCICLOVIR SODIUM
Applicant:Custopharm Inc
Ingredient:ganciclovir sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 20, 2019TE:RLD:No

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