Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075015
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/1998 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
12/05/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

07/09/2002 SUPPL-3 Labeling

Label is not available on this site.

08/21/2000 SUPPL-1 Labeling

Label is not available on this site.

ACYCLOVIR 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
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 075015 FRESENIUS KABI USA
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205771 HIKMA PHARMS
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203927 MYLAN LABS LTD
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206606 ZYDUS PHARMS USA INC

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