NDA 215700

INFORLIFE SA

FDA Drug Application

Application #215700

Documents

• Label: 2022-09-16
• Letter: 2022-09-16

Application Sponsors

NDA 215700

INFORLIFE SA

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	4MG(16MCG PER ML)0.9%	0	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE
002	INJECTABLE;INJECTION	8MG(32MCG PER ML)0.9%	0	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE
003	INJECTABLE;INJECTION	16MG(64MCG PER ML)0.9%	0	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-09-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

INFORLIFE SA

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(
    [0] => Array
        (
            [ApplNo] => 215700
            [companyName] => INFORLIFE SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE","activeIngredients":"NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE","strength":"4MG(16MCG PER ML)0.9%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE","activeIngredients":"NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE","strength":"8MG(32MCG PER ML)0.9%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE","activeIngredients":"NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE","strength":"16MG(64MCG PER ML)0.9%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/15\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215700s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215700s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215700Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-15
        )

)