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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020089
Company: MYLAN

Products on NDA 020089

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOVIRAX	ACYCLOVIR	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ZOVIRAX	ACYCLOVIR	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020089

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1991	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2008	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf
12/09/2005	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,019909s020ltr.pdf
05/19/2004	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr019,20089slr018ltr.pdf
11/14/2001	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf
11/14/2001	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf
07/12/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/10/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/15/2000	SUPPL-12	Labeling		Label is not available on this site.
05/29/1997	SUPPL-11	Labeling		Label is not available on this site.
01/08/1997	SUPPL-10	Labeling		Label is not available on this site.
10/29/1996	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/12/1995	SUPPL-7	Labeling		Label is not available on this site.
09/07/1995	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/14/1994	SUPPL-4	Labeling		Label is not available on this site.
11/09/1993	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/26/1992	SUPPL-2	Efficacy-New Indication	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020089s002_zovirax_toc.cfm
04/22/1993	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020089

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/09/2005	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf
05/19/2004	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf
11/14/2001	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf
11/14/2001	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20089s15s16lbl.pdf

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