FDA.reportPublic FDA data

Application 205122

Type
NDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUDEXY XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL25MGYesNo
002QUDEXY XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL50MGYesNo
003QUDEXY XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL100MGYesNo
004QUDEXY XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL150MGYesNo
005QUDEXY XRTOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-1071QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1071QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1071QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1071QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1071QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1071QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1072QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1072QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1072QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1072QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1072QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1072QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1073QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1073QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1073QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1073QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1073QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1073QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1074QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1074QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1074QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1074QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1074QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1074QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1075QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1075QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1075QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1075QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1075QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0245-1075QUDEXYTopiramateUpsher-Smith Laboratories, LLCNDACurrent
0832-1071TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1071TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1071TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1071TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1071TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1072TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1072TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1072TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1072TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1072TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1073TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1073TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1073TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1073TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1073TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1074TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1074TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1074TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1074TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1074TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1075TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1075TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1075TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1075TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1075TopiramateTopiramateUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85338SUPPL 2026-03-12
85304SUPPL 2026-03-09
85356SUPPL 2026-03-06
81585SUPPL 2025-03-17
81563SUPPL 2025-03-14
78024SUPPL 2024-04-01
78004SUPPL 2024-03-28
72790SUPPL2022-12-05
72789SUPPL2022-12-05
72788SUPPL2022-12-05
70119SUPPL2022-02-08
70118SUPPL2022-02-08
70111SUPPL2022-02-08
66307SUPPL2021-02-22
66299SUPPL2021-02-19
61910SUPPL2020-02-19
61909SUPPL2020-02-19
61907SUPPL2020-02-18
57791SUPPL2019-02-22
57790SUPPL2019-02-22
57775SUPPL2019-02-22
47793SUPPL2017-03-30
47792SUPPL2017-03-30
47783SUPPL2017-03-30
47782SUPPL2017-03-30
47781SUPPL2017-03-30
47780SUPPL2017-03-30
10428SUPPL2016-04-20
44915ORIG2015-05-14
22976ORIG2015-05-14
10427SUPPL2015-04-02
40448SUPPL2015-04-01
40447ORIG2014-03-13
32634ORIG2014-03-13