Hikma Pharmaceuticals International Limited FDA Approval NDA 213330

NDA 213330

Hikma Pharmaceuticals International Limited

FDA Drug Application

Application #213330

Documents

Letter2020-11-10
Label2020-11-12

Application Sponsors

NDA 213330Hikma Pharmaceuticals International Limited

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INJECTION100mg/100mL0LABETALOL HYDROCHLORIDE IN DEXTROSELABETALOL HYDROCHLORIDE
002INJECTABLE;INJECTION200mg/200mL0LABETALOL HYDROCHLORIDE IN DEXTROSELABETALOL HYDROCHLORIDE
003INJECTABLE;INJECTION300mg/300mL0LABETALOL HYDROCHLORIDE IN DEXTROSELABETALOL HYDROCHLORIDE
004SOLUTION;INTRAVENOUS300MG/300ML (1MG/ML)1LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDELABETALOL HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-11-09STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213330
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE IN DEXTROSE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"200MG\/200ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"100MG\/100ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"200MG\/200ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"300MG\/300ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/09\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213330s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/09\/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\\\/213330s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213330Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-11-09
        )

)

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