NDA 214047

REGULIANCE LLC

FDA Drug Application

Application #214047

Documents

• Letter: 2020-12-01
• Label: 2020-12-04
• Review: 2021-07-06

Application Sponsors

NDA 214047

REGULIANCE LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; ORAL

100MCG/5ML

0

THYQUIDITY

LEVOTHYROXINE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-11-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

REGULIANCE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214047
            [companyName] => REGULIANCE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THYQUIDITY","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG\/5ML","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214047Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-30
        )

)