ANDA 210944

MACLEODS PHARMS LTD

FDA Drug Application

Application #210944

Application Sponsors

ANDA 210944

MACLEODS PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET;ORAL	12.5MG	0	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE
003	TABLET;ORAL	50MG	0	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE
004	TABLET;ORAL	100MG	0	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-11-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210944
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MILNACIPRAN HYDROCHLORIDE","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MILNACIPRAN HYDROCHLORIDE","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MILNACIPRAN HYDROCHLORIDE","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MILNACIPRAN HYDROCHLORIDE","activeIngredients":"MILNACIPRAN HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-02
        )

)