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… 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 | Meridia (sibutramine HCL monohydrate), Abbott Labs, Labeling Revision | Meridia (sibutramine hydrochloride monohydrate) Capsules, Global Pharma, Patient Population Altered | Meridia (Sibutramine Hydrochloride Monohydrate) Capsules, Abbott Labs, Labeling Revision | Meridia Capsule, Abbott, 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