Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090658
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/21/2010 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
06/08/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

GANCICLOVIR SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090658 FRESENIUS KABI USA
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204204 HAINAN POLY PHARM
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 076222 HIKMA
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204950 PAR STERILE PRODUCTS
GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207645 PHARMASCIENCE INC

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