Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022580
Company: VIVUS
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 None Yes No
QSYMIA PHENTERMINE HYDROCHLORIDE; TOPIRAMATE EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
QSYMIA PHENTERMINE HYDROCHLORIDE; TOPIRAMATE EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
QSYMIA PHENTERMINE HYDROCHLORIDE; TOPIRAMATE EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None 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
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
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

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