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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022483
Company: BAUSCH

Summary Review

Products on NDA 022483

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYCLARA	IMIQUIMOD	3.75%	CREAM;TOPICAL	Prescription	AB	Yes	Yes
ZYCLARA	IMIQUIMOD	2.5%	CREAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022483

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022483s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483_zyclara_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/14/2012	SUPPL-6	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022483s006ltr.pdf
07/15/2011	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s003ltr.pdf
09/29/2011	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s002ltr.pdf
03/24/2011	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001ltr.pdf

Labels for NDA 022483

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2012	SUPPL-6	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf
09/29/2011	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf
07/15/2011	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf
03/24/2011	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf
03/25/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf

Therapeutic Equivalents for NDA 022483

ZYCLARA

CREAM;TOPICAL; 3.75%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMIQUIMOD	IMIQUIMOD	3.75%	CREAM;TOPICAL	Prescription	No	AB	205971	TARO
ZYCLARA	IMIQUIMOD	3.75%	CREAM;TOPICAL	Prescription	Yes	AB	022483	BAUSCH

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