Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021478
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOVIRAX ACYCLOVIR 5% CREAM;TOPICAL Prescription AB Yes 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 208702 PERRIGO UK FINCO
ZOVIRAX ACYCLOVIR 5% CREAM;TOPICAL Prescription Yes AB 021478 BAUSCH

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