ANDA 209369

RHODES PHARMS

FDA Drug Application

Application #209369

Application Sponsors

ANDA 209369

RHODES PHARMS

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

002	TABLET;ORAL	75MG	0	TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE
003	TABLET;ORAL	100MG	0	TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-09-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209369
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAPENTADOL HYDROCHLORIDE","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TAPENTADOL HYDROCHLORIDE","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TAPENTADOL HYDROCHLORIDE","activeIngredients":"TAPENTADOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/14\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-14
        )

)