Drugs@FDA: FDA Approved Drug Products

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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 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.

GANCICLOVIR

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
CYTOVENE GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 019661 ROCHE PALO
GANCICLOVIR GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090658 FRESENIUS KABI USA
GANCICLOVIR GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204204 HAINAN POLY PHARM
GANCICLOVIR GANCICLOVIR SODIUM EQ 500MG BASE/ViAL INJECTABLE;INJECTION Prescription No AP 204560 MYLAN LABS LTD
GANCICLOVIR 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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