Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2009 Betterchem.com