Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022580
Company: VIVUS LLC
Company: VIVUS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/29/2026 | SUPPL-32 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022580s032lbl.pdf | |
| 03/06/2026 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022580s031lbl.pdf | |
| 07/11/2025 | SUPPL-29 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022580s029lbl.pdf | |
| 11/19/2024 | SUPPL-26 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf | |
| 09/13/2024 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s025lbl.pdf | |
| 06/28/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022580s023lbl.pdf | |
| 06/24/2022 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022580s021lbl.pdf | |
| 03/31/2021 | SUPPL-19 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022580s019lbl.pdf | |
| 10/19/2020 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf | |
| 10/19/2020 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf | |
| 03/23/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf | |
| 03/23/2018 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf | |
| 09/26/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf | |
| 09/26/2014 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf | |
| 09/26/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf | |
| 09/26/2014 | SUPPL-10 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf | |
| 04/16/2013 | SUPPL-4 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf | |
| 03/19/2013 | SUPPL-5 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s005lbl.pdf |
| 11/01/2012 | SUPPL-1 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s001lbl.pdf | |
| 07/17/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf |