ANDA 215657

GLAND PHARMA LTD

FDA Drug Application

Application #215657

Application Sponsors

ANDA 215657

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 300MG BASE/ML

0

LINCOMYCIN HYDROCHLORIDE

LINCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215657
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINCOMYCIN HYDROCHLORIDE","activeIngredients":"LINCOMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-26
        )

)