Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018927
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEGRETOL CARBAMAZEPINE 100MG/5ML SUSPENSION;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
12/18/1987 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-55 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
07/08/2016 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/17/2016 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

11/08/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

12/11/2012 SUPPL-48 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-47 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-46 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-44 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
04/23/2009 SUPPL-43 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-42 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
03/03/2011 SUPPL-41 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-40 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-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018927s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf
08/28/2015 SUPPL-38 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-35 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
12/11/2002 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/28/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/2001 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/07/2001 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF
04/11/2000 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/08/2000 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/10/2000 SUPPL-28 Labeling

Label is not available on this site.

12/29/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/15/1998 SUPPL-25 Labeling

Label is not available on this site.

04/10/2000 SUPPL-24 Labeling

Label is not available on this site.

07/15/1998 SUPPL-23 Labeling

Label is not available on this site.

01/02/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1998 SUPPL-21 Labeling

Label is not available on this site.

07/15/1998 SUPPL-20 Labeling

Label is not available on this site.

08/09/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/11/1995 SUPPL-18 Efficacy-New Patient Population

Label is not available on this site.

10/06/1993 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1991 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1990 SUPPL-8 Labeling

Label is not available on this site.

08/01/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/21/1989 SUPPL-5 Labeling

Label is not available on this site.

04/07/1989 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1988 SUPPL-3 Labeling

Label is not available on this site.

07/28/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/28/1988 SUPPL-1 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
03/20/2018 SUPPL-55 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-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf
09/16/2014 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf
01/16/2014 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf
03/06/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf
12/11/2012 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf
03/03/2011 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf
03/03/2011 SUPPL-42 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf
03/03/2011 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf
04/23/2009 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf
12/11/2007 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018927s039lbl.pdf
08/16/2007 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf
03/07/2001 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF

TEGRETOL

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription No AB 075714 WOCKHARDT BIO AG
TEGRETOL CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription Yes AB 018927 NOVARTIS
TERIL CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription No AB 076729 TARO

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