FDA Approval Activities for this Drug…

Meridia (sibutramine hydrochloride monohydrate) Capsule, Abbott NDA 20-632/17 9/25/03 9/30/03 Meridia (sibutramine hydrochloride monohydrate) Capsule, Knoll Pharmaceutical NDA 20-632/S-008/11 2/16/01 2/27/01 2/27/01 Meridia Indications: Management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. | Meridia (Sibutramine HCL Monohydrate) Capsules, Abbott, Labeling Revision & Package Change

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