ANDA 214397

MACLEODS PHARMS LTD

FDA Drug Application

Application #214397

Application Sponsors

ANDA 214397

MACLEODS PHARMS LTD

Marketing Status

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

Application Products

001	UNKNOWN	UNKNOWN	0	DOLUTEGRAVIR SODIUM	DOLUTEGRAVIR SODIUM
002	TABLET;ORAL	EQ 25MG BASE	0	DOLUTEGRAVIR SODIUM	DOLUTEGRAVIR SODIUM
003	TABLET;ORAL	EQ 50MG BASE	0	DOLUTEGRAVIR SODIUM	DOLUTEGRAVIR SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214397
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-22
        )

)