ANDA 090194

HOSPIRA

FDA Drug Application

Application #090194

Application Sponsors

ANDA 090194

HOSPIRA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	SOLUTION;INJECTION	20MG/10ML (2MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
002	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
003	SOLUTION;INJECTION	150MG/20ML (7.5MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
004	SOLUTION;INJECTION	100MG/10ML (10MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
005	SOLUTION;INJECTION	40MG/20ML (2MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
006	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2014-09-23

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP
005	Prescription	AP
006	Prescription	AP

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90194
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"20MG\/10ML (2MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"150MG\/30ML (5MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"150MG\/20ML (7.5MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"40MG\/20ML (2MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROPIVACAINE HYDROCHLORIDE","submission":"ROPIVACAINE HYDROCHLORIDE","actionType":"20MG\/10ML (2MG\/ML)","submissionClassification":"SOLUTION;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPIVACAINE HYDROCHLORIDE","submission":"ROPIVACAINE HYDROCHLORIDE","actionType":"150MG\/30ML (5MG\/ML)","submissionClassification":"SOLUTION;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPIVACAINE HYDROCHLORIDE","submission":"ROPIVACAINE HYDROCHLORIDE","actionType":"150MG\/20ML (7.5MG\/ML)","submissionClassification":"SOLUTION;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPIVACAINE HYDROCHLORIDE","submission":"ROPIVACAINE HYDROCHLORIDE","actionType":"100MG\/10ML (10MG\/ML)","submissionClassification":"SOLUTION;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPIVACAINE HYDROCHLORIDE","submission":"ROPIVACAINE HYDROCHLORIDE","actionType":"40MG\/20ML (2MG\/ML)","submissionClassification":"SOLUTION;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROPIVACAINE HYDROCHLORIDE","submission":"ROPIVACAINE HYDROCHLORIDE","actionType":"200MG\/20ML (10MG\/ML)","submissionClassification":"SOLUTION;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)