ANDA 211304

SLAYBACK PHARMA LLC

FDA Drug Application

Application #211304

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 211304

SLAYBACK PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10MG BASE/ML

0

METARAMINOL BITARTRATE

METARAMINOL BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

SLAYBACK PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211304
            [companyName] => SLAYBACK PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METARAMINOL BITARTRATE","activeIngredients":"METARAMINOL BITARTRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-24
        )

)