Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022012
Company: WAYLIS THERAP
Company: WAYLIS THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COREG CR | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| COREG CR | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| COREG CR | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| COREG CR | CARVEDILOL PHOSPHATE | 80MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 12/19/2008 | ORIG-11 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
||
| 10/20/2006 | ORIG-1 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022012s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022012s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/26/2023 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022012s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022012Orig1s024ltr.pdf | |
| 09/14/2017 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022012s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022012Orig1s022ltr.pdf | |
| 10/02/2015 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022012s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022012Orig1s021ltr.pdf | |
| 07/06/2011 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020ltr.pdf | |
| 01/06/2011 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022012s017,s019ltr.pdf | |
| 01/06/2011 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022012s017,s019ltr.pdf | |
| 01/25/2011 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s033,022012s016ltr.pdf | |
| 06/23/2009 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022012s010,s013ltr.pdf | |
| 12/19/2008 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022012s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022012s011ltr.pdf | |
| 06/23/2009 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022012s010,s013ltr.pdf | |
| 10/19/2007 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s004ltr.pdf | |
| 08/03/2007 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s003ltr.pdf | |
| 07/16/2007 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/26/2023 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022012s024lbl.pdf | |
| 09/14/2017 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022012s022lbl.pdf | |
| 10/02/2015 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022012s021lbl.pdf | |
| 07/06/2011 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s020lbl.pdf | |
| 01/25/2011 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s016lbl.pdf | |
| 01/06/2011 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf | |
| 01/06/2011 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf | |
| 06/23/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf | |
| 06/23/2009 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf | |
| 12/19/2008 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022012s011lbl.pdf | |
| 10/19/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s004lbl.pdf | |
| 08/03/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s003lbl.pdf | |
| 07/16/2007 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s001lbl.pdf | |
| 10/20/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022012lbl.pdf |
COREG CR
CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WAYLIS THERAP |
CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WAYLIS THERAP |
CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WAYLIS THERAP |
CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WAYLIS THERAP |