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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021478
Company: BAUSCH

Products on NDA 021478

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOVIRAX	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021478

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21478_zovirax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-478_Zovirax_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-478_Zovirax.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021478s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021478Orig1s010ltr.pdf
02/03/2015	SUPPL-8	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/21478Orig1s008.pdf
04/01/2014	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021478s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021478Orig1s007ltr.pdf
01/23/2004	SUPPL-3	Manufacturing (CMC)-Packaging	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21478scp003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021478_S003_Zovirax_APPROVAL_PACKAGE.pdf

Labels for NDA 021478

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021478s010lbl.pdf
12/23/2020	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021478s010lbl.pdf
12/23/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021478s010lbl.pdf
04/01/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021478s007lbl.pdf
12/30/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21478_zovirax_lbl.pdf

Therapeutic Equivalents for NDA 021478

ZOVIRAX

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	212361	ALEMBIC
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	208766	AMNEAL
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	208702	PADAGIS ISRAEL
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	206770	ZYDUS LIFESCIENCES
ZOVIRAX	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	Yes	AB	021478	BAUSCH

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