Application 213876

Type
NDA
Sponsor
DIURNAL LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALKINDI SPRINKLEHYDROCORTISONECAPSULE;ORAL0.5MGNoNo
002ALKINDI SPRINKLEHYDROCORTISONECAPSULE;ORAL1MGNoNo
003ALKINDI SPRINKLEHYDROCORTISONECAPSULE;ORAL2MGNoNo
004ALKINDI SPRINKLEHYDROCORTISONECAPSULE;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71863-109AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-109AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-109AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-109AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-109AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-110AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-110AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-110AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-110AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-110AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-111AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-111AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-111AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-111AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-111AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-112AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-112AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-112AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-112AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent
71863-112AlkindiHydrocortisoneEton Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78729SUPPL 2024-07-02
78668SUPPL 2024-06-06
78667SUPPL 2024-06-06
73052SUPPL2022-12-27
73044SUPPL2022-12-27
73043SUPPL2022-12-27
70098SUPPL2022-02-07
70097SUPPL2022-02-07
70084SUPPL2022-02-04
68655ORIG2021-09-20
64773ORIG2020-10-01
64764ORIG2020-09-30