Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020165
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICODERM CQ NICOTINE 21MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter None Yes Yes
NICODERM CQ NICOTINE 14MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter None Yes No
NICODERM CQ NICOTINE 7MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/07/1991 ORIG-1 Approval Type 3 - New Dosage Form 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
05/04/2016 SUPPL-38 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20165Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020165Orig1s038ltr.pdf
10/26/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/07/2015 SUPPL-36 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s036ltr.pdf
08/06/2015 SUPPL-35 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s035ltr.pdf
02/03/2015 SUPPL-34 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s034ltr.pdf
10/31/2013 SUPPL-31 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020165Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020165Orig1s031ltr.pdf
04/30/2014 SUPPL-29 Labeling-Container/Carton Labels, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020165Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020165Orig1s029ltr.pdf
09/20/2012 SUPPL-28 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020165Orig1s028ltr.pdf
02/20/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/13/2007 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020165s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020165s024ltr.pdf
09/15/2006 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020165s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020165s023ltr.pdf
08/13/2002 SUPPL-20 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20165slr020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020165_S020_NICODERM CQ.pdf
06/08/2001 SUPPL-19 Labeling

Label is not available on this site.

09/21/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/16/2000 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/16/2000 SUPPL-16 Labeling

Label is not available on this site.

09/14/1999 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/21/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/11/1997 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/02/1996 SUPPL-11 Efficacy-Rx To OTC Switch

Label is not available on this site.

01/23/1996 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/19/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/22/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/22/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/04/2016 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20165Orig1s038lbl.pdf
10/07/2015 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s036lbl.pdf
08/06/2015 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s035lbl.pdf
02/03/2015 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s034lbl.pdf
04/30/2014 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020165Orig1s029lbl.pdf
04/30/2014 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020165Orig1s029lbl.pdf
10/31/2013 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020165Orig1s031lbl.pdf
04/13/2007 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020165s024lbl.pdf
09/15/2006 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020165s023lbl.pdf

NICODERM CQ

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

FILM, EXTENDED RELEASE;TRANSDERMAL; 7MG/24HR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HABITROL NICOTINE 7MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter Yes 020076 DR REDDYS LABS SA
NICODERM CQ NICOTINE 7MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter Yes 020165 SANOFI AVENTIS US
NICOTINE NICOTINE 7MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter No 074612 AVEVA

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

FILM, EXTENDED RELEASE;TRANSDERMAL; 21MG/24HR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HABITROL NICOTINE 21MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter Yes 020076 DR REDDYS LABS SA
NICODERM CQ NICOTINE 21MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter Yes 020165 SANOFI AVENTIS US
NICOTINE NICOTINE 21MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter No 074612 AVEVA

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

FILM, EXTENDED RELEASE;TRANSDERMAL; 14MG/24HR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HABITROL NICOTINE 14MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter Yes 020076 DR REDDYS LABS SA
NICODERM CQ NICOTINE 14MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter Yes 020165 SANOFI AVENTIS US
NICOTINE NICOTINE 14MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter No 074612 AVEVA

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