NDA 214253

CUSTOPHARM INC

FDA Drug Application

Application #214253

Documents

• Letter: 2021-05-18
• Label: 2021-05-18
• Review: 2021-10-12

Application Sponsors

NDA 214253

CUSTOPHARM INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

100MCG/ML

2

LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-05-17

STANDARD

Submissions Property Types

ORIG

1

Null

6

TE Codes

001

None (Tentative Approval)

TBD

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214253
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG\/ML","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214253s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/17\/2021","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\\\/2021\\\/214253s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214253Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-17
        )

)