Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020723
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDARA IMIQUIMOD 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ALDARA

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALDARA IMIQUIMOD 5% CREAM;TOPICAL Prescription Yes AB 020723 MEDICIS
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 091308 APOTEX INC
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 078548 FOUGERA PHARMS
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 200481 G AND W LABS INC
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 201994 GLENMARK GENERICS
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 078837 PERRIGO ISRAEL
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 202002 STRIDES PHARMA
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 200173 TARO
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 091044 TOLMAR

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