FDA.reportPublic FDA data

Application 210833

Type
NDA
Sponsor
AQUESTIVE THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMPAZANCLOBAZAMFILM;ORAL5MGYesNo
002SYMPAZANCLOBAZAMFILM;ORAL10MGYesNo
003SYMPAZANCLOBAZAMFILM;ORAL20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10094-205SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-205SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-205SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-205SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-205SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-210SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-210SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-210SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-210SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-210SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-220SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-220SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-220SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-220SYMPAZANclobazamAquestive TherapeuticsNDACurrent
10094-220SYMPAZANclobazamAquestive TherapeuticsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77812SUPPL 2024-03-13
77809SUPPL 2024-03-13
77808SUPPL 2024-03-13
73211SUPPL2023-01-17
73210SUPPL2023-01-17
73184SUPPL2023-01-17
66810SUPPL2021-03-18
66809SUPPL2021-03-18
66798SUPPL2021-03-17
66157SUPPL2021-02-09
66156SUPPL2021-02-09
66141SUPPL2021-02-09
65566SUPPL2020-12-10
57035ORIG2018-12-26
55467ORIG2018-11-06
56249ORIG2018-11-02
56248ORIG2018-11-02