Phentermine / topiramate Extended Release Oral Capsule

Brand(s)
Qsymia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Vivus, Inc. (2014-10-01)
Oldest Current Product
2012-09-17
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\PHENTERMINE:TOPIRAMATE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\PHENTERMINE HYDROCHLORIDE: TOPIRAMATE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\PHENTERMINE HYDROCHLORIDE: TOPIRAMATE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\PHENTERMINE: TOPIRAMATE

product(s) by strength(s)

24 hr phentermine 11.25 mg / topiramate 69 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625410203QsymiaNDAVivus, Inc.2012-09-17PHENTERMINE HYDROCHLORIDE, TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA02258040dd5602-53da-45ac-bb4b-15789aba40f9

24 hr phentermine 15 mg / topiramate 92 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625410204QsymiaNDAVivus, Inc.2012-09-17PHENTERMINE HYDROCHLORIDE, TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA02258040dd5602-53da-45ac-bb4b-15789aba40f9

24 hr phentermine 3.75 mg / topiramate 23 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625410201QsymiaNDAVivus, Inc.2012-09-17PHENTERMINE HYDROCHLORIDE, TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA02258040dd5602-53da-45ac-bb4b-15789aba40f9

24 hr phentermine 7.5 mg / topiramate 46 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625410202QsymiaNDAVivus, Inc.2012-09-17PHENTERMINE HYDROCHLORIDE, TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA02258040dd5602-53da-45ac-bb4b-15789aba40f9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022580QSYMIAVIVUS INC2012-07-17p9011905, SUBSTANCE
p8895057, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT
p7659256, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, SUBSTANCE
p8895058, SUBSTANCE
p8580298, SUBSTANCE
p8580299, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT
p7674776, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, SUBSTANCE
p7056890, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, SUBSTANCE
p9011906, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT
p6071537, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT
p7553818, USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT
NEW COMBINATION [2015-07-17]NDA022580_001, NDA022580_002, NDA022580_003, NDA022580_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022580_001RXPHENTERMINE HYDROCHLORIDE (EQ 3.75MG BASE), TOPIRAMATE (23MG)ORALCAPSULE, EXTENDED RELEASEFalse2012-07-17QSYMIA
2NDA022580_002RXTOPIRAMATE (46MG), PHENTERMINE HYDROCHLORIDE (EQ 7.5MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse2012-07-17QSYMIA
3NDA022580_003RXTOPIRAMATE (69MG), PHENTERMINE HYDROCHLORIDE (EQ 11.25MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse2012-07-17QSYMIA
4NDA022580_004RXPHENTERMINE HYDROCHLORIDE (EQ 15MG BASE), TOPIRAMATE (92MG)ORALCAPSULE, EXTENDED RELEASETrue2012-07-17QSYMIA

patent(s)

#idexpiration dateapplication(s)
1p6071537 (view patent)2017-06-23NDA022580
2p7056890 (view patent)2020-06-14NDA022580
3p7553818 (view patent)2020-06-14NDA022580
4p7659256 (view patent)2020-06-14NDA022580
5p7674776 (view patent)2020-06-14NDA022580
6p8580298 (view patent)2029-05-15NDA022580
7p8580299 (view patent)2029-06-14NDA022580
8p8895057 (view patent)2028-06-09NDA022580
9p8895058 (view patent)2028-06-09NDA022580
10p9011905 (view patent)2028-06-09NDA022580
11p9011906 (view patent)2028-06-09NDA022580

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
140dd5602-53da-45ac-bb4b-15789aba40f9 (view SPL)These highlights do not include all the information needed to use QSYMIA safely and effectively. See full prescribing information for QSYMIA. QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV Initial U.S. Approval: 2012prescriptionHuman PrescriptionVivus, Inc.2014-10-0113625410201, 625410202, 625410203, 625410204

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII