SINTETICA, SA FDA Approval NDA 213536

NDA 213536

SINTETICA, SA

FDA Drug Application

Application #213536

Documents

Letter2021-06-15
Label2021-06-15

Application Sponsors

NDA 213536SINTETICA, SA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION4.7MG/ML0REZIPRESEPHEDRINE HYDROCHLORIDE
002INJECTABLE;INJECTION9.4MG/ML0REZIPRESEPHEDRINE HYDROCHLORIDE
003INJECTABLE;INJECTION47MG/ML0REZIPRESEPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-06-14STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

SINTETICA, SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213536
            [companyName] => SINTETICA, SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"REZIPRES","activeIngredients":"EPHEDRINE HYDROCHLORIDE","strength":"4.7MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"REZIPRES","activeIngredients":"EPHEDRINE HYDROCHLORIDE","strength":"9.4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"REZIPRES","activeIngredients":"EPHEDRINE HYDROCHLORIDE","strength":"47MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213536s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/14\/2021","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\\\/2021\\\/213536s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213536Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-14
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.