Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022012
Company: WOODWARD
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
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
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 WOODWARD

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 WOODWARD

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 WOODWARD

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 WOODWARD

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