NDA 208609

AKORN INC

FDA Drug Application

Application #208609

Documents

• Label: 2017-03-02
• Letter: 2017-03-03
• Review: 2018-03-09

Application Sponsors

NDA 208609

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

50MG/ML (50MG/ML)

0

EPHEDRINE SULFATE

EPHEDRINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2017-03-01

STANDARD

Submissions Property Types

ORIG

1

Null

40

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208609
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPHEDRINE SULFATE","activeIngredients":"EPHEDRINE SULFATE","strength":"50MG\/ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/01\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208609s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/01\/2017","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\\\/2017\\\/208609s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208609Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208609Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/03\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-07-03
        )

)