ANDA 216662

HAINAN POLY

FDA Drug Application

Application #216662

Application Sponsors

ANDA 216662

HAINAN POLY

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 300MG BASE/ML

0

LINCOMYCIN HYDROCHLORIDE

LINCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

HAINAN POLY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216662
            [companyName] => HAINAN POLY
            [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":"12\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-21
        )

)