ANDA 212129

NANJING KING-FRIEND

FDA Drug Application

Application #212129

Application Sponsors

ANDA 212129

NANJING KING-FRIEND

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	200MG/5.26ML (38MG/ML)	0	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	1GM/26.3ML (38MG/ML)	0	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	2GM/52.6ML (38MG/ML)	0	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

NANJING KING-FRIEND

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212129
            [companyName] => NANJING KING-FRIEND
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"200MG\/5.26ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"1GM\/26.3ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"2GM\/52.6ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-11
        )

)