Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018281
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEGRETOL | CARBAMAZEPINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/14/1981 | 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 |
|---|---|---|---|---|---|
| 03/20/2018 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/016608Orig1s116,018281Orig1s058,018927Orig1s055,020234Orig1s047ltr.pdf | |
| 11/08/2013 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf | |
| 10/30/2011 | SUPPL-54 | REMS-Modified |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf | |
| 01/16/2014 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf | |
| 03/03/2011 | SUPPL-50 | REMS-Proposal, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf | |
| 03/03/2011 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf | |
| 04/23/2009 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032ltr.pdf | |
| 09/16/2014 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf | |
| 12/11/2007 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf | |
| 08/28/2015 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf | |
| 08/16/2007 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf | |
| 03/05/2002 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/2001 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018281_S039_TEGRETOL_AP.PDF | |
| 04/11/2000 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/27/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-31 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/018927_S031_TEGRETOL_AP.PDF |
| 07/15/1998 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/06/1993 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/1991 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/23/1992 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/03/1995 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/29/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/11/1995 | SUPPL-10 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/11/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1986 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/10/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/10/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/21/1983 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/11/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/20/2018 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf | |
| 08/28/2015 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf | |
| 09/16/2014 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf | |
| 01/16/2014 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf | |
| 03/06/2013 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf | |
| 12/11/2012 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf | |
| 03/03/2011 | SUPPL-50 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 03/03/2011 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 03/03/2011 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 04/23/2009 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf | |
| 12/11/2007 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf | |
| 08/16/2007 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf | |
| 03/07/2001 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF |