NDA 215809

MYLAN PHARMS INC

FDA Drug Application

Application #215809

Documents

• Label: 2022-04-29
• Letter: 2022-08-31
• Review: 2022-11-21

Application Sponsors

NDA 215809

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

150MCG/5ML

0

ERMEZA

LEVOTHYROXINE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

0000-00-00

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215809
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERMEZA","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"150MCG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215809s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215809s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-04-29
        )

)