NDA 213330

Hikma Pharmaceuticals International Limited

FDA Drug Application

Application #213330

Documents

• Letter: 2020-11-10
• Label: 2020-11-12
• Review: 2021-06-28

Application Sponsors

NDA 213330

Hikma Pharmaceuticals International Limited

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	100mg/100mL	0	LABETALOL HYDROCHLORIDE IN DEXTROSE	LABETALOL HYDROCHLORIDE
002	INJECTABLE;INJECTION	200mg/200mL	0	LABETALOL HYDROCHLORIDE IN DEXTROSE	LABETALOL HYDROCHLORIDE
003	INJECTABLE;INJECTION	300mg/300mL	0	LABETALOL HYDROCHLORIDE IN DEXTROSE	LABETALOL HYDROCHLORIDE
004	SOLUTION;INTRAVENOUS	300MG/300ML (1MG/ML)	1	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	LABETALOL HYDROCHLORIDE
005	SOLUTION;INTRAVENOUS	10MG/2ML (5MG/ML)	1	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-11-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)