Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020297
Company: SMITHKLINE BEECHAM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COREG CARVEDILOL 25MG TABLET;ORAL Prescription AB Yes No
COREG CARVEDILOL 12.5MG TABLET;ORAL Prescription AB Yes Yes
COREG CARVEDILOL 6.25MG TABLET;ORAL Prescription AB Yes No
COREG CARVEDILOL 3.125MG TABLET;ORAL Prescription AB 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
09/14/1995 ORIG-1 Approval Type 1 - New Molecular Entity 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
09/14/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020297s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020297Orig1s038ltr.pdf
10/02/2015 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020297s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020297Orig1s037ltr.pdf
07/06/2011 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020ltr.pdf
01/06/2011 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf
01/06/2011 SUPPL-34 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf
01/25/2011 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s033,022012s016ltr.pdf
12/19/2008 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s030ltr.pdf
06/23/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020297s029ltr.pdf
07/22/2008 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s028ltr.pdf
02/23/2007 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020297s022ltr.pdf
12/20/2006 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s021ltr.pdf
09/05/2006 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s020_ltr.pdf
08/28/2006 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s018ltr.pdf
08/16/2005 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s017ltr.pdf
04/29/2005 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s013ltr.pdf
09/29/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297slr011ltr.pdf
03/27/2003 SUPPL-9 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297se1-009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-297s009_Coreg.cfm
11/08/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/2001 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg.cfm
07/10/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/25/2000 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/08/1999 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20297s4_Coreg.pdf
07/28/1998 SUPPL-3 Labeling

Label is not available on this site.

05/20/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1997 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/14/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020297s038lbl.pdf
10/02/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020297s037lbl.pdf
07/06/2011 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s036lbl.pdf
01/25/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf
01/06/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf
01/06/2011 SUPPL-34 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf
06/23/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf
12/19/2008 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s030lbl.pdf
07/22/2008 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s028lbl.pdf
02/23/2007 SUPPL-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf
08/28/2006 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf
04/29/2005 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf
11/01/2001 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_prntlbl.pdf

COREG

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078165 APOTEX INC
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077474 CIPLA LTD
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077346 SUN PHARM INDS INC
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 25MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 25MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078165 APOTEX INC
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077474 CIPLA LTD
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077346 SUN PHARM INDS INC
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 12.5MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 12.5MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

TABLET;ORAL; 6.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078165 APOTEX INC
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077474 CIPLA LTD
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077346 SUN PHARM INDS INC
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 6.25MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 6.25MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

TABLET;ORAL; 3.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078165 APOTEX INC
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078332 AUROBINDO PHARMA
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078384 BEXIMCO USA
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077474 CIPLA LTD
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 076649 DR REDDYS LABS LTD
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078251 GLENMARK GENERICS
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078217 LUPIN
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077316 MYLAN
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 078227 SANDOZ
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077346 SUN PHARM INDS INC
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 076989 SUN PHARM INDS LTD
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077780 TARO
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 076373 TEVA
CARVEDILOL CARVEDILOL 3.125MG TABLET;ORAL Prescription No AB 077614 ZYDUS PHARMS USA INC
COREG CARVEDILOL 3.125MG TABLET;ORAL Prescription Yes AB 020297 SMITHKLINE BEECHAM

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