FDA.reportPublic FDA data

Application 211635

Type
NDA
Sponsor
NEURELIS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALTOCODIAZEPAMSPRAY;NASAL5MG/SPRAYYesNo
002VALTOCODIAZEPAMSPRAY;NASAL7.5MG/SPRAYYesNo
003VALTOCODIAZEPAMSPRAY;NASAL10MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72252-505ValtocodiazepamNeurelis, IncNDACurrent
72252-505ValtocodiazepamNeurelis, IncNDACurrent
72252-505ValtocodiazepamNeurelis, IncNDACurrent
72252-505ValtocodiazepamNeurelis, IncNDACurrent
72252-510ValtocodiazepamNeurelis, IncNDACurrent
72252-510ValtocodiazepamNeurelis, IncNDACurrent
72252-510ValtocodiazepamNeurelis, IncNDACurrent
72252-510ValtocodiazepamNeurelis, IncNDACurrent
72252-515ValtocodiazepamNeurelis, IncNDACurrent
72252-515ValtocodiazepamNeurelis, IncNDACurrent
72252-515ValtocodiazepamNeurelis, IncNDACurrent
72252-515ValtocodiazepamNeurelis, IncNDACurrent
72252-520ValtocodiazepamNeurelis, IncNDACurrent
72252-520ValtocodiazepamNeurelis, IncNDACurrent
72252-520ValtocodiazepamNeurelis, IncNDACurrent
72252-520ValtocodiazepamNeurelis, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83289SUPPL 2025-10-27
83288SUPPL 2025-10-27
82005SUPPL 2025-04-25
80656SUPPL 2025-04-21
73213SUPPL2023-01-17
73212SUPPL2023-01-17
73187SUPPL2023-01-17
70126SUPPL2022-02-08
70125SUPPL2022-02-08
70112SUPPL2022-02-08
66159SUPPL2021-02-09
66158SUPPL2021-02-09
66143SUPPL2021-02-09
64552ORIG2020-09-10
61558ORIG2020-01-14
61556ORIG2020-01-13
61555ORIG2020-01-13