ANDA 078601

NAVINTA LLC

FDA Drug Application

Application #078601

Application Sponsors

ANDA 078601

NAVINTA LLC

Marketing Status

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

Application Products

001	INJECTABLE; INJECTION	5MG/ML(0.5%)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
002	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
003	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2014-07-17

Submissions Property Types

ORIG

1

Null

15

TE Codes

002	Prescription	AP
003	Prescription	AP

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78601
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"5MG\/ML(0.5%)","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","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":"200MG\/20ML (10MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROPIVACAINE HYDROCHLORIDE","submission":"ROPIVACAINE HYDROCHLORIDE","actionType":"5MG\/ML(0.5%)","submissionClassification":"INJECTABLE; 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":"200MG\/20ML (10MG\/ML)","submissionClassification":"SOLUTION;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)