ANDA 214811

AMNEAL

FDA Drug Application

Application #214811

Application Sponsors

ANDA 214811

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 2% BASE

0

MUPIROCIN

MUPIROCIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214811
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MUPIROCIN","activeIngredients":"MUPIROCIN CALCIUM","strength":"EQ 2% BASE","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-15
        )

)