ANDA 204842

HIKMA PHARMS

FDA Drug Application

Application #204842

Application Sponsors

ANDA 204842

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	0.25%	0	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	0.5%	0	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	0.75%	0	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204842
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE","strength":"0.25%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE","strength":"0.75%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-11
        )

)