ANDA 210102

GLAND PHARMA LTD

FDA Drug Application

Application #210102

Application Sponsors

ANDA 210102

GLAND PHARMA LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-10-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210102
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-03
        )

)