Drug application
QSYMIA (PHENTERMINE HYDROCHLORIDE, TOPIRAMATE)
Drugs@FDA NDA 022580 · VIVUS LLC
Key facts
| Drug name | QSYMIA |
|---|---|
| Active ingredients | PHENTERMINE HYDROCHLORIDE, TOPIRAMATE |
| Application type | NDA |
| Application number | 022580 |
| Company | VIVUS LLC |
| Dosage forms | CAPSULE, EXTENDED RELEASE, ORAL |
| Strength | EQ 3.75MG BASE;23MG |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Jul 17, 2012 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: