Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020297
Company: WOODWARD
Company: WOODWARD
| 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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020297Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/26/2023 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020297Orig1s039correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020297Orig1s039correctedltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 07/26/2023 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020297Orig1s039correctedlbl.pdf | |
| 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 | 078332 | AUROBINDO PHARMA |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078384 | BEXIMCO USA |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 077474 | CHARTWELL MOLECULAR |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 076649 | DR REDDYS LABS LTD |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078251 | GLENMARK PHARMS LTD |
| 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 | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| 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 | WOODWARD |
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 | 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 | CHARTWELL MOLECULAR |
| 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 PHARMS LTD |
| 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 | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| 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 | WOODWARD |
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 | 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 | CHARTWELL MOLECULAR |
| 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 PHARMS LTD |
| 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 | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| 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 | WOODWARD |
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 | 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 | CHARTWELL MOLECULAR |
| 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 PHARMS LTD |
| 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 | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| 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 | WOODWARD |