ANDA 211091

EXELA PHARMA SCS LLC

FDA Drug Application

Application #211091

Application Sponsors

ANDA 211091

EXELA PHARMA SCS LLC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	0.5MEQ/ML	0	SODIUM BICARBONATE	SODIUM BICARBONATE
002	INJECTABLE;INJECTION	0.9MEQ/ML	0	SODIUM BICARBONATE	SODIUM BICARBONATE
003	INJECTABLE;INJECTION	1MEQ/ML	0	SODIUM BICARBONATE	SODIUM BICARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211091
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"0.5MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"0.9MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"1MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-20
        )

)