FDA.reportPublic FDA data

Application 022580

Type
NDA
Sponsor
VIVUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QSYMIAPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 3.75MG BASE;23MGYesNo
002QSYMIAPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 7.5MG BASE;46MGYesNo
003QSYMIAPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 11.25MG BASE;69MGYesNo
004QSYMIAPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 15MG BASE;92MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62541-201Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-201Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-201Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-201Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-201Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-201Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-201Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-201Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-202Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-202Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-202Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-202Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-202Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-202Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-202Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-202Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-203Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-203Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-203Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-203Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-203Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-203Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-203Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-203Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-204Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-204Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-204Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-204Qsymiaphentermine and topiramateVivus, Inc.NDACurrent
62541-204Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-204Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-204Qsymiaphentermine and topiramateVivus LLCNDACurrent
62541-204Qsymiaphentermine and topiramateVivus LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85330SUPPL 2026-03-12
85296SUPPL 2026-03-09
85352SUPPL 2026-03-06
82873SUPPL 2025-07-15
82830SUPPL 2025-07-14
80255SUPPL 2024-11-21
80252SUPPL 2024-11-20
79632SUPPL 2024-09-16
79598SUPPL 2024-09-16
77413SUPPL 2024-02-07
74662SUPPL 2023-06-29
74657SUPPL 2023-06-29
74203SUPPL 2023-05-10
71491SUPPL2022-06-30
71455SUPPL2022-06-27
71454SUPPL2022-06-27
71453SUPPL2022-06-27
70441SUPPL2022-03-09
66962SUPPL2021-04-01
66945SUPPL2021-04-01
64961SUPPL2020-10-21
64957SUPPL2020-10-21
64956SUPPL2020-10-21
53506SUPPL2018-03-29
53464SUPPL2018-03-27
53463SUPPL2018-03-27
38864SUPPL2014-09-30
29887SUPPL2014-09-30
29886SUPPL2014-09-30
17744SUPPL2014-09-30
17743SUPPL2014-09-30
7568SUPPL2014-09-30
29885SUPPL2013-04-18
17742SUPPL2013-04-17
24345ORIG2013-04-08
22066ORIG2013-04-08
38863SUPPL2013-03-26
7567SUPPL2012-11-06
17741SUPPL2012-11-02
38862ORIG2012-07-18
29884ORIG2012-07-18
24037ORIG2012-07-18