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 Discontinued None 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
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.

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