ANDA 212514

SPIL

FDA Drug Application

Application #212514

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 212514

SPIL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE, LIPOSOMAL;INJECTION

50MG/VIAL

0

AMPHOTERICIN B

AMPHOTERICIN B

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

SPIL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212514
            [companyName] => SPIL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHOTERICIN B","activeIngredients":"AMPHOTERICIN B","strength":"50MG\/VIAL","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-14
        )

)