Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074930
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML 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
05/13/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74930ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74930ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/2005 SUPPL-4 Labeling

Label is not available on this site.

05/24/2002 SUPPL-2 Labeling

Label is not available on this site.

05/10/2000 SUPPL-1 Labeling

Label is not available on this site.

ACYCLOVIR SODIUM

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203701 AUROBINDO PHARMA LTD
ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074930 FRESENIUS KABI USA

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