ANDA 211188

MEDEFIL INC

FDA Drug Application

Application #211188

Application Sponsors

ANDA 211188

MEDEFIL INC

Marketing Status

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

Application Products

001	LIQUID;N/A	100% (1ML)	0	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION
002	LIQUID;N/A	100% (2.5ML)	0	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION
003	LIQUID;N/A	100% (3ML)	0	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION
004	LIQUID;N/A	100% (5ML)	0	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION
005	LIQUID;N/A	100% (10ML)	0	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-08-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

004	Prescription	AP
005	Prescription	AP

CDER Filings

MEDEFIL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211188
            [companyName] => MEDEFIL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"STERILE WATER FOR INJECTION","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100% (1ML)","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"STERILE WATER FOR INJECTION","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100% (2.5ML)","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"STERILE WATER FOR INJECTION","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100% (3ML)","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"STERILE WATER FOR INJECTION","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100% (5ML)","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"STERILE WATER FOR INJECTION","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100% (10ML)","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/26\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-26
        )

)