| NDC Code: |
62541-203 |
| Proprietary Name: |
Qsymia |
| Suffix: |
|
| Non-Proprietary Name: |
phentermine and topiramate |
| Dosage Form: |
CAPSULE, EXTENDED RELEASE |
| Method: |
ORAL |
| Original Marketing Date: |
17-09-2012 |
| Category Name: |
NDA |
| Application Number: |
NDA022580 |
| Labeler: |
VIVUS, INC. |
| Substance Name: |
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE |
| Active Numerator Strength: |
11.25; 69 |
| Active Ingredient Unit: |
mg/1; mg/1 |
| Pharm Classes: |
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule: |
CIV |
