Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020165
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| 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 |
|---|---|---|---|---|---|
| 03/04/2022 | SUPPL-47 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020165Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020165Orig1s047ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/04/2022 | SUPPL-47 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020165Orig1s047lbl.pdf | |
| 03/04/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020165Orig1s047lbl.pdf | |
| 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 | CHATTEM SANOFI |
| 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 | CHATTEM SANOFI |
| 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 | CHATTEM SANOFI |
| NICOTINE | NICOTINE | 14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | No | 074612 | AVEVA |