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FDA Approval Activities for this Drug
Starlix (nateglinide) Tablets, Novartis NDA 21-204/S6 1020/03 10/27/03 10/27/03
Starlix (nateglinide) Tablets, 60 mg and 120 mg., Novartis NDA 21-204/S5 11/26/02 12/9/02 12/4/02
Starlix (nateglinide) Tablets, 60 mg and 120 mg. Novartis NDA 21-204 12/22/00 1/9/01 1/9/01 3/18/02
Starlix Indication: Provides for the use of Starlix as monotherapy, as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. In addition, it provides for the use of Starlix concomitantly with metformin to improve glycemic control. Risperdal Consta (risperidone) Long -Acting Injection, Johnson & Johnson Starlix (nateglinide) Tablets, Novartis Pharmaceuticals, Labeling Revision | Nateglinide Tablets, Par Pharma, Tentative Approval | Starlix (nateglinide) Tablets, Novartis Pharma, Labeling Revision | Nateglinide Tablets, Teva Pharma, Tentative Appproval | Nateglinide Tablets, Watson Labs, Tentative Approval | Starlix (nateglinide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Nateglinide Tablets, Dr. Reddy’s Laboratories Ltd., Approval | Nateglinide Tablets, Par Pharmaceutical, Inc., Approval | Nateglinide Tablets, Teva Pharmaceuticals, Approval | Nateglinide Tablets, Watson Laboratories, Inc., Approval | Starlix (nateglinide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
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