NDA 213407

NEXUS PHARMS

FDA Drug Application

Application #213407

Documents

• Label: 2020-04-20
• Letter: 2020-04-20
• Review: 2020-07-21

Application Sponsors

NDA 213407

NEXUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/10ML

2

EMERPHED

EPHEDRINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-04-17

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

NEXUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213407
            [companyName] => NEXUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMERPHED","activeIngredients":"EPHEDRINE SULFATE","strength":"50MG\/10ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/17\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213407s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/17\/2020","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\\\/2020\\\/213407s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213407Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213407Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-17
        )

)