NDA 202832

MEDEFIL INC

FDA Drug Application

Application #202832

Documents

• Letter: 2012-10-02
• Letter: 2012-01-10
• Label: 2012-09-28
• Review: 2012-10-25
• Letter: 2017-12-01
• Letter: 2022-10-28
• Label: 2022-10-31

Application Sponsors

NDA 202832

MEDEFIL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Prescription: 006

Application Products

001	INJECTABLE;INJECTION	9MG/ML (9MG/ML)	1	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE
002	INJECTABLE;INJECTION	18MG/2ML (9MG/ML)	1	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE
003	INJECTABLE;INJECTION	22.5MG/2.5ML (9MG/ML)	1	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE
004	INJECTABLE;INJECTION	27MG/3ML (9MG/ML)	1	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE
005	INJECTABLE;INJECTION	45MG/5ML (9MG/ML)	1	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE
006	INJECTABLE;INJECTION	90MG/10ML (9MG/ML)	1	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2012-01-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-11-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-10-26	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15
SUPPL	6	Null	15

CDER Filings

MEDEFIL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202832
            [companyName] => MEDEFIL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM CHLORIDE","strength":"18MG\/2ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM CHLORIDE","strength":"22.5MG\/2.5ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM CHLORIDE","strength":"27MG\/3ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM CHLORIDE","strength":"45MG\/5ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM CHLORIDE","strength":"90MG\/10ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"9MG\/ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/27\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202832s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202832s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/06\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202832s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202832_sodiumc_toc.cfm\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/29\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202832Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/27\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202832s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202832Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2017-11-29
        )

)