ANDA 216445

ASPIRO

FDA Drug Application

Application #216445

Application Sponsors

ANDA 216445

ASPIRO

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

350MG/VIAL

0

DAPTOMYCIN

DAPTOMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ASPIRO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216445
            [companyName] => ASPIRO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-23
        )

)