ANDA 212296

SLAYBACK PHARMA LLC

FDA Drug Application

Application #212296

Documents

• Letter: 2021-05-06

Application Sponsors

ANDA 212296

SLAYBACK PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

20MG/2ML (10MG/ML)

0

DEOXYCHOLIC ACID

DEOXYCHOLIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

SLAYBACK PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212296
            [companyName] => SLAYBACK PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEOXYCHOLIC ACID","activeIngredients":"DEOXYCHOLIC ACID","strength":"20MG\/2ML (10MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-02
        )

)