FDA Approval Activities for this Drug…

Singulair (Montelukast Sodium) Granules, 4 mg, Merck Research NDA 21-409/S3 12/31/02 1/23/03 4/9/03 Singulair (Montelukast Sodium) Granules, Merck Research NDA 21-409 7/26/02 8/6/02 7/30/02 Singulair (Montelukast Sodium) Tablets & Chewable Tablets & Granules, Merck Research NDA 20-829/S23 & 20-830/S26 & 21-409/S5 10/2/03 10/9/03 10/10/03 Singulair (Montelukast Sodium) Tablets & Chewable Tablets & Granules, 10 mg, 4 & 5 mg & 4 mg, Merck Research NDA 20-829/S17 & 20-830/S20 & 21-409/S3 12/31/02 1/23/03 4/7/03 Singulair (montelukast sodium) Chewable Tablets, Merck & Co., NDA 20-829/S12 08/02/01 08/02/01 Singulair (Montelukast Sodium) Tablets, Merck Research NDA 20-829 & 20-830 2/20/98 9/10/98 12/8/98 5/24/01 Singulair (Montelukast Sodium) Tablets, 10 mg, Merck Research NDA 20-829/S001 2/12/99 7/5/01 Singulair (Montelukast Sodium) Chewable Tablets, 5 mg, Merck Research NDA 20-830/S001 2/12/99 7/5/01 Singulair (Montelukast Sodium) Chewable Tablets, 4 mg, Merck NDA 20-830/S-8 3/3/00 9/7/01 Singulair (montelukast sodium) Chewable Tablets, Merck & Co. NDA 20-830/S-011 11/23/01 11/25/02 04/24/03 Singulair Indication: prophylaxis for asthma in children 2-5 years of age. Singulair (Montelukast Sodium) Tablets & Chewable Tablets, Merck Research Singulair (Montelukast Sodium) Tablets & Chewable Tablets & Oral Granules, Merck Research Laboratories | Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Inc., Labeling Revision | Singulair (montelukast sodium) Oral Granules, Merck & Co., Inc., Labeling Revision | Singulair (montelukast sodium) Tablets, Merck & Co., Inc., Labeling Revision | Singulair (montelukast sodium) Tablets, Merck & Co., Labeling Revision | Singulair (montelukast sodium) Chewable tablets, Merck & Co., Labeling Revision | Singulair (montelukast sodium) Oral granules, Merck & Co., Labeling Revision

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