Phentermine and Topiramate Extended-Release
Phentermine and Topiramate Extended-Release is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Phentermine and Topiramate Extended-Release. Available dosage form: capsule.
Drug Details
- Generic Name
- Phentermine and Topiramate Extended-Release
- Brand Names
- Phentermine and Topiramate Extended-Release
- Application Number
- ANDA208175
- Sponsor
- Dr.Reddys Laboratories Inc
- NDC Codes
- 4
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- PHENTERMINE HYDROCHLORIDE, TOPIRAMATE
Indications and Usage
1 INDICATIONS AND USAGE Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adult patients with obesity Adults with overweight in the presence of at least one weight-related comorbid condition Limitations of Use • The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established. • The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. Phentermine and topiramate extended-release capsules are a combination of phentermine, a sympathomimetic amine anorectic, and topiramate indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adult patients with obesity ( 1 ) Adults with overweight in the presence of at least one weight-related comorbid condition Limitations of Use: The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established ( 1 ). The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established ( 1 ).