Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016608
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEGRETOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/11/1968 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016608_Tegretol.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/13/2023 | SUPPL-121 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016608s121_018927s60_020234s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020234Orig1s054;018927Orig1s060;016608Orig1s121ltr.pdf | |
| 03/20/2018 | SUPPL-116 | 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/2018/016608Orig1s116,018281Orig1s058,018927Orig1s055,020234Orig1s047ltr.pdf | |
| 10/30/2015 | SUPPL-111 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/2013 | SUPPL-108 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-107 | 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-106 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf |
| 03/06/2013 | SUPPL-105 | 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-103 | 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-102 | 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-101 | 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/2009/016608s101,018927s043ltr.pdf | |
| 03/03/2011 | SUPPL-100 | Labeling, REMS-Proposal |
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 | |
| 09/16/2014 | SUPPL-99 | 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-98 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf | |
| 08/28/2015 | SUPPL-97 | 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-96 | 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 | |
| 01/28/2002 | SUPPL-94 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/2001 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/2001 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-90 | 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/2001/016608_S090_TEGRETOL_AP.pdf | |
| 04/11/2000 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-88 | Labeling |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1999 | SUPPL-86 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-82 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-79 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/06/1993 | SUPPL-77 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/1991 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1990 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1990 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 03/28/1990 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1990 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1990 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1989 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1988 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 08/08/1988 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1995 | SUPPL-59 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 02/03/1986 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 01/10/1986 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 06/02/1986 | SUPPL-54 | Efficacy |
Label is not available on this site. |
||
| 01/10/1986 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 05/06/1985 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1985 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1984 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1983 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-48 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1982 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/08/1981 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 02/01/1980 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1980 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1978 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 08/09/1978 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 04/04/1977 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1977 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1977 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/12/1975 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/1975 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1976 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 07/02/1975 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/1974 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1974 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1975 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/20/1974 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1974 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1974 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1974 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1974 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1974 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1974 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1974 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1974 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1974 | SUPPL-12 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/13/2023 | SUPPL-121 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016608s121_018927s60_020234s054lbl.pdf | |
| 03/20/2018 | SUPPL-116 | 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-97 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf | |
| 09/16/2014 | SUPPL-99 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf | |
| 01/16/2014 | SUPPL-103 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf | |
| 03/06/2013 | SUPPL-105 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf | |
| 12/11/2012 | SUPPL-107 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf | |
| 03/03/2011 | SUPPL-102 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 03/03/2011 | SUPPL-100 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 03/03/2011 | SUPPL-100 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 04/23/2009 | SUPPL-101 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf | |
| 12/11/2007 | SUPPL-98 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf | |
| 08/16/2007 | SUPPL-96 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf | |
| 03/07/2001 | SUPPL-90 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF |
TEGRETOL
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 075948 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 218221 | BIONPHARMA |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 074649 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 077272 | TORRENT PHARMS |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 207798 | UMEDICA |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 213284 | UNICHEM |
| EPITOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 070541 | TEVA |
| TEGRETOL | CARBAMAZEPINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 016608 | NOVARTIS |