ANDA 211087

FRESENIUS KABI USA

FDA Drug Application

Application #211087

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 211087

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	14.9MG/ML	0	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE
002	INJECTABLE;INJECTION	746MG/100ML	0	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE
003	INJECTABLE;INJECTION	29.8MG/ML	0	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE
004	INJECTABLE;INJECTION	2.98GM/100ML	0	POTASSIUM CHLORIDE 40MEQ	POTASSIUM CHLORIDE
005	INJECTABLE;INJECTION	1.49GM/100ML	0	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP
005	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211087
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 10MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"14.9MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 10MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"746MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"29.8MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 40MEQ","activeIngredients":"POTASSIUM CHLORIDE","strength":"2.98GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-09
        )

)