NDA 216109

HIKMA PHARMACEUTICALS USA, INC

FDA Drug Application

Application #216109

Documents

• Letter: 2022-10-11
• Label: 2022-10-11

Application Sponsors

NDA 216109

HIKMA PHARMACEUTICALS USA, INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 2GM/VIAL	0	ANCEF	CEFAZOLIN
002	INJECTABLE;INJECTION	EQ 3GM/VIAL	0	ANCEF	CEFAZOLIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-10-07

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

HIKMA PHARMACEUTICALS USA, INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216109
            [companyName] => HIKMA PHARMACEUTICALS USA, INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANCEF","activeIngredients":"CEFAZOLIN","strength":"EQ 2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ANCEF","activeIngredients":"CEFAZOLIN","strength":"EQ 3GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216109s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/07\/2022","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\\\/2022\\\/216109s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216109Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-10-07
        )

)