ANDA 215106

AMNEAL

FDA Drug Application

Application #215106

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 215106

AMNEAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	4MG	0	DEXAMETHASONE	DEXAMETHASONE
002	TABLET;ORAL	6MG	0	DEXAMETHASONE	DEXAMETHASONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215106
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-14
        )

)