ANDA 216413

ASPIRO

FDA Drug Application

Application #216413

Application Sponsors

ANDA 216413

ASPIRO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

DAPTOMYCIN

DAPTOMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ASPIRO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216413
            [companyName] => ASPIRO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-23
        )

)