ANDA 206166

INFORLIFE

FDA Drug Application

Application #206166

Documents

• Letter: 2018-07-16

Application Sponsors

ANDA 206166

INFORLIFE

Marketing Status

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

Application Products

001	SOLUTION;INJECTION	200MG/100ML (2MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
002	SOLUTION;INJECTION	400MG/200ML (2MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
003	SOLUTION;INJECTION	500MG/100ML (5MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE
004	SOLUTION;INJECTION	1GM/200ML (5MG/ML)	0	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-06-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-11-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

INFORLIFE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206166
            [companyName] => INFORLIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"400MG\/200ML (2MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"500MG\/100ML (5MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"1GM\/200ML (5MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206166Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/14\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-14
        )

)