FDA.reportPublic FDA data

Application 022445

Type
NDA
Sponsor
HERON THERAPS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUSTOLGRANISETRONINJECTION, EXTENDED RELEASE;SUBCUTANEOUS10MG/0.4ML (10MG/0.4ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47426-101SUSTOLgranisetronHeron TherapeuticsNDACurrent
47426-101SUSTOLgranisetronHeron TherapeuticsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85149SUPPL 2026-02-24
85128SUPPL 2026-02-24
85148SUPPL 2026-02-23
74385SUPPL 2023-05-26
74383SUPPL 2023-05-26
74378SUPPL 2023-05-26
55494ORIG2018-09-18
45514ORIG2016-10-12
45017ORIG2016-08-09
45015ORIG2016-08-09