NDA 211379

DEXCEL PHARMA

FDA Drug Application

Application #211379

Documents

• Label: 2019-10-03
• Letter: 2019-10-04
• Review: 2019-12-27
• Letter: 2021-06-28
• Label: 2021-06-28

Application Sponsors

NDA 211379

DEXCEL PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG

1

HEMADY

DEXAMETHASONE

FDA Submissions

TYPE 4/5;	ORIG	1	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-06-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

DEXCEL PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211379
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEMADY","activeIngredients":"DEXAMETHASONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/03\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211379s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/03\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211379s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211379Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211379Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-10-03
        )

)