Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016608
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
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 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-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
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 REMS-Proposal 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
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 074649 TARO
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 077272 TORRENT PHARMS
EPITOL CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 070541 TEVA
TEGRETOL CARBAMAZEPINE 200MG TABLET;ORAL Prescription Yes AB 016608 NOVARTIS

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