NDA 214566

AB PHARMACEUTICALS, LLC

FDA Drug Application

Application #214566

Documents

• Letter: 2021-03-17

Application Sponsors

NDA 214566

AB PHARMACEUTICALS, LLC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL SUSPENSION

10MG

0

DOLUTEGRAVIR SODIUM

DOLUTEGRAVIR SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2021-03-16

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

AB PHARMACEUTICALS, LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214566
            [companyName] => AB PHARMACEUTICALS, LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"10MG","dosageForm":"TABLET; ORAL SUSPENSION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214566Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-16
        )

)