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QSYMIA (nda022580)- (EQ 3.75MG BASE;23MG,EQ 7.5MG BASE;46MG,EQ 11.25MG BASE;69MG,EQ 15MG BASE;92MG)

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC
EQ 3.75MG BASE;23MG,EQ 7.5MG BASE;46MG,EQ 11.25MG BASE;69MG,EQ 15MG BASE;92MG
Yes Yes
2029-Jun-14 Expired
None None
None No
QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: • Adults with an initial body mass index (BMI) of: o 30 kg/m2 or greater (obese) or o 27 kg/m2 or greater (overweight) in the presence of at least one weightrelated comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia • Pediatric patients aged 12 years and older with BMI in the 95th percentile or greater standardized for age and sex.
0 0 0
Total Other Developers 5
Drugs with Suitability No
EQ 3.75MG BASE;23MG ** ** - - -
EQ 7.5MG BASE;46MG ** ** - - -
EQ 11.25MG BASE;69MG ** ** - - -
EQ 15MG BASE;92MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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