ALDARA از شرکت BAUSCH

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ALDARA از شرکت BAUSCH

New Drug Application (NDA): 020723

Company: BAUSCH

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 BAUSCH
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 201994 GLENMARK GENERICS
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 078837 PERRIGO ISRAEL
IMIQUIMOD IMIQUIMOD 5% CREAM;TOPICAL Prescription No AB 200173 TARO
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