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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

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