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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020723
Company: BAUSCH

Products on NDA 020723

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALDARA	IMIQUIMOD	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020723

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	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
09/25/2024	SUPPL-28	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020723s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020723Orig1s028ltr.pdf
02/03/2015	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
11/26/2014	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
10/14/2010	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020723s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020723s022ltr.pdf
03/22/2007	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020723s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020723s020LTR.pdf
08/09/2005	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020723s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020723s018ltr.pdf
07/14/2004	SUPPL-16	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020723_S016_ALDARA_CREAM.pdf
03/02/2004	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723se1-015_aldara_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20723se1-015ltr.pdf
09/03/2002	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf
09/03/2002	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr011,012ltr.pdf
12/15/2002	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20723slr010ltr.pdf
03/28/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/27/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
03/07/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
03/07/2000	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/20/1998	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/08/1997	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/07/1997	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/08/2001	SUPPL-1	Labeling	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20723s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020723Orig1s001.pdf

Labels for NDA 020723

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2024	SUPPL-28	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020723s028lbl.pdf
09/25/2024	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020723s028lbl.pdf
10/14/2010	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020723s022lbl.pdf
03/22/2007	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020723s020lbl.pdf
08/09/2005	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020723s018lbl.pdf
07/14/2004	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf
03/02/2004	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723se1-015_aldara_lbl.pdf
12/15/2002	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf
09/03/2002	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf
09/03/2002	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf
12/08/2001	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20723s1lbl.pdf

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