NDA 213876

DIURNAL LTD

FDA Drug Application

Application #213876

Documents

• Letter: 2020-09-30
• Label: 2020-10-01
• Review: 2021-09-20
• Letter: 2022-02-04
• Label: 2022-02-07
• Medication Guide: 2022-02-07
• Label: 2022-12-27
• Medication Guide: 2022-12-27
• Letter: 2022-12-27

Application Sponsors

NDA 213876

DIURNAL LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	0.5MG	0	ALKINDI SPRINKLE	HYDROCORTISONE
002	CAPSULE;ORAL	1MG	0	ALKINDI SPRINKLE	HYDROCORTISONE
003	CAPSULE;ORAL	2MG	0	ALKINDI SPRINKLE	HYDROCORTISONE
004	CAPSULE;ORAL	5MG	0	ALKINDI SPRINKLE	HYDROCORTISONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-09-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6

CDER Filings

DIURNAL LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213876
            [companyName] => DIURNAL LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALKINDI SPRINKLE","activeIngredients":"HYDROCORTISONE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/29\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213876s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213876s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213876Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-09-29
        )

)