Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018603
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOVIRAX ACYCLOVIR SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
ZOVIRAX ACYCLOVIR SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
ZOVIRAX ACYCLOVIR SODIUM EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
10/22/1982 ORIG-1 Approval Type 2 - New Active Ingredient and Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018603s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018603Orig1s030ltr.pdf
05/19/2004 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18603slr027_zovirax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18603slr027ltr.pdf
01/29/2002 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf
01/29/2002 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf
01/29/2002 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf
07/12/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/15/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1999 SUPPL-20 Labeling

Label is not available on this site.

06/02/1998 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/18603s19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18603s19ltr.pdf
10/29/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/14/1994 SUPPL-15 Labeling

Label is not available on this site.

11/09/1993 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1993 SUPPL-13 Labeling

Label is not available on this site.

07/17/1992 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1989 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/22/1993 SUPPL-10 Labeling

Label is not available on this site.

02/09/1990 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

07/09/1984 SUPPL-8 Labeling

Label is not available on this site.

05/31/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/14/1984 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/08/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/30/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/09/1990 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

01/05/1983 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/14/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2019 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018603s030lbl.pdf
05/19/2004 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18603slr027_zovirax_lbl.pdf
06/02/1998 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/18603s19lbl.pdf

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