Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English