Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020234
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEGRETOL-XR | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| TEGRETOL-XR | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| TEGRETOL-XR | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/25/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/020234lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/020234ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020234_complete_Approval_pkg.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/13/2023 | SUPPL-54 | 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-47 | 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 | |
| 07/29/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-40 | 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-39 | 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-38 | 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-35 | 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-33 | 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-32 | 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 | |
| 03/03/2011 | SUPPL-31 | 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/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf | |
| 09/16/2014 | SUPPL-30 | 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-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020234s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf | |
| 08/28/2015 | SUPPL-26 | 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-25 | 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-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/2002 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-17 | 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/2001/020234_S017_TEGRETOL_AP.pdf | |
| 04/11/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/14/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1999 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/04/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
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-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016608s121_018927s60_020234s054lbl.pdf | |
| 03/20/2018 | SUPPL-47 | 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-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf | |
| 09/16/2014 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf | |
| 01/16/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf | |
| 03/06/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf | |
| 12/11/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf | |
| 03/03/2011 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 03/03/2011 | SUPPL-31 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 03/03/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf | |
| 04/23/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf | |
| 12/11/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020234s028lbl.pdf | |
| 08/16/2007 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf | |
| 03/07/2001 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF | |
| 03/25/1996 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/020234lbl.pdf |
TEGRETOL-XR
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216404 | RICONPHARMA LLC |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216235 | SCIECURE PHARMA INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216594 | UMEDICA |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215591 | ZHEJIANG JIUZHOU |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216404 | RICONPHARMA LLC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216235 | SCIECURE PHARMA INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216594 | UMEDICA |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215591 | ZHEJIANG JIUZHOU |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212948 | ANBISON LAB |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213311 | CSPC OUYI |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216404 | RICONPHARMA LLC |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216235 | SCIECURE PHARMA INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078115 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216594 | UMEDICA |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211623 | UNIQUE PHARM |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215591 | ZHEJIANG JIUZHOU |
| CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205571 | ZYDUS PHARMS |
| TEGRETOL-XR | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020234 | NOVARTIS |