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FDA Approval Activities for this Drug…
Coreg (carvedilol) Tablets, 3.125, 6.25, 12.5 and 25 mg GlaxoSmithKline NDA 20297/S011 9/29/03 9/30/03 Coreg (Carvedilol) Tablets, 3.125mg, 6.25mg, 12.5mg, & 25mg. GlaxoSmithKline NDA 20297/S009 3/27/03 4/1/03 7/8/03 Coreg (Carvedilol) Tablets, 3.125mg, 6.25mg, 12.5mg, & 25mg. GlaxoSmithKline NDA 20297/S007 11/1/01 3/28/02 3/28/02 3/28/02 Coreg (Carvedilol) Tablets, 3.125mg, 6.25mg, 12.5mg, & 25mg. SmithKline Beecham NDA 20297/S004 Carvedilol Tablets, TEVA Pharmaceuticals | Carvedilol Tablet, Ranbaxy, Tentative Approval | Coreg (carvedilol) Tablets, GlaxoSmithKline, New or Modified Indication | Coreg (carvedilol) Tablets, SmithKline Beecham, Labeling Revision | Carvedilol Tablets, Caraco Pharma, Tentative Approval | Carvedilol Tablets, Watson Labs, Tentative Approval | Carvedilol Tablets, Caraco Pharma, Tentative Approval | Carvedilol Tablets, Mylan Pharma, Tentative Approval | Carvedilol Tablets, Zydus Pharma, Tentative Approval | Carvedilol Tablets, Taro Pharma, Tentative Approval | Coreg Tablet, Glaxosmithkline, Labeling Revision | Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision | Coreg CR (carvedilol phosphate) Extended-Release Capsules, GlaxoSmithKline, Approval | Carvedilol Tablets, Hikma Pharma, Tentative Approval | Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision | Coreg (carvedilol) Tablets, GlaxoSmithKline, Patient Population Altered | Coreg CR (carvedilol phosphate) Extended Release Capsules, SB Pharmco, Labeling Revision | Coreg CR (carvedilol phosphate) Extended Release Capsules, SB Pharma, Labeling Revision | Carvedilol Tablets, Actavis Elizabeth, Tentative Approval | Carvedilol Tablets, Sandoz Inc., Tentative Approval | Carvedilol Tablets, Actavis Elizabeth, Approval | Carvedilol Tablets, Apotex Corp., Approval | Carvedilol Tablets, Caraco Pharma, Approval | Carvedilol Tablets, Dr. Reddy’s Labs, Approval | Carvedilol Tablets, Mylan Pharma, Approval | Carvedilol Tablets, Ranbaxy, Approval | Carvedilol Tablets, Sandoz Inc., Approval | Carvedilol Tablets, Taro Pharma, Approval | Carvedilol Tablets, Teva Pharma, Approval | Carvedilol Tablets, Watson Labs, Approval | Carvedilol Tablets, Zydus Pharma, Approval | Carvedilol Tablets, Glenmark Pharma, Approval | Carvedilol Tablets, Aurobindo Pharma, Approval | Carvedilol Tablets, Lupin, Approval | Carvedilol Tablets, Hikma Pharma, Approval | Coreg CR (carvedilol phosphate) Extended-release Capsules, SB Pharmco, Labeling Revision | Carvedilol Tablets, Pliva Hrvatska, Approval | Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision | Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision | Coreg CR (carvedilol phosphate) Extended-Release Capsules, GlaxoSmithKline, Approval | Carvedilol Tablets, Hikma Pharmaceuticals, Labeling | Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision | Coreg CR (carvedilol phosphate) Extended-Release Capsules, GlaxoSmithKline, Labeling Revision | Carvedilol Tablets, Wockhardt Limited, Approval | Coreg (carvedilol) Tablets, SmithKline Beecham, Labeling Revision | Coreg CR (carvedilol phosphate) Extended-Release Tablets, SmithKline Beecham, Labeling Revision | Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision | Coreg CR (carvedilol phosphate) Extended-Release Capsules, GlaxoSmithKline, Labeling Revision | Coreg (carvedilol) Tablets, SmithKline Beecham, Labeling Revision | Coreg CR (carvedilol phosphate) Extended Release Capsules, SmithKline Beecham, Labeling Revision
  
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