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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/17/2012 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Origs000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000_qsymia_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/19/2024 | SUPPL-26 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022580Orig1s026ltr.pdf | |
| 09/13/2024 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022580Orig1s025ltr.pdf | |
| 02/06/2024 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022580Orig1s024ltr.pdf |
| 06/28/2023 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022580s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022580Orig1s023ltr.pdf | |
| 05/09/2023 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022580Orig1s022ltr.pdf |
| 06/24/2022 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022580s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022580Orig1s021ltr.pdf | |
| 03/08/2022 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022580Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022580Orig1s020.pdf |
| 03/31/2021 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022580s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022580Orig1s019ltr.pdf | |
| 10/19/2020 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022580Orig1s017ltr.pdf | |
| 03/23/2018 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022580rig1s016ltr.pdf | |
| 01/27/2017 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf | |
| 09/26/2014 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf | |
| 09/26/2014 | SUPPL-10 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf | |
| 09/24/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/2013 | SUPPL-5 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s005lbl.pdf | |
| 04/16/2013 | SUPPL-4 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022580Orig1s004ltr.pdf | |
| 11/01/2012 | SUPPL-1 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 |
QSYMIA
CAPSULE, EXTENDED RELEASE;ORAL; EQ 3.75MG BASE;23MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 7.5MG BASE;46MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 11.25MG BASE;69MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 15MG BASE;92MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |