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… Merck Withdraws VIOXX Vioxx (rofecoxib tablets) Tablets, 12.5 mg and 25 mg., Merck Research NDA 21-042 5/20/99 5/21/99 5/21/99 4/17/00 Vioxx Indication: For relief of the signs and symptoms of osteoarthritis. For the management of acute pain. For the treatment of primary dysmenorrhea. Vioxx (rofecoxib) Tablets & Suspension, Merck & Co. NDA 21-042/S18 & 21-052/S12 8/6/03 8/15/03 8/15/03 Vioxx (rofecoxib) Tablets & Suspension, Merck & Co. NDA 21-042/S-017 &21-052/S-011 5/19/03 Vioxx (rofecoxib) Tablets & Suspension, 12.5, 25, 50 mg & 12.5 mg/mL and 25 mg/mL respectively, Merck & Co. NDA 21-042/S-020, S-021, S-022 & 21-052/S-014, S-015, S-016 6/27/03 7/6/03 Vioxx (rofecoxib) Tablets & Suspension, 12.5, 25, 50 mg & 12.5 mg/mL and 25 mg/mL respectively, Merck & Co. NDA 21-042/S-007, S-008, S-010, S-012, S-013, S-014 & NDA 21-052/S-004, S-005, S-006, S-007, S-008, S-009 4/11/02 4/16/02 4/16/02 7/25/02 Vioxx (rofecoxib oral suspension) Suspension, 12.5 mg/mL and 25 mg/mL, Merck Research NDA 21-052 5/20/99 6/30/00 Vioxx Indication: For relief of the signs and symptoms of osteoarthritis. For the management of acute pain. For the treatment of primary dysmenorrhea. Vioxx (rofecoxib) Tablets & Suspension, Merck & Co. Inc. | Vioxx TM (rofecoxib) Tablets, Merck & Co. Inc. Vioxx (rofecoxib) Tablets, Merck & Co. Inc. | Vioxx (rofecoxib) Tablets and Suspension, Merck & Co., Inc., Patient Population Altered | Vioxx (rofecoxib) Tablets and Suspension, Merck & Co., Inc., Patient Population Altered | | Vioxx (rofecoxib) Suspension, Merck & Co., Labeling Revision | Vioxx (rofecoxib) Tablets, Merck & Co., 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 © 2008 Betterchem.com