ANDA 208837

DR REDDYS

FDA Drug Application

Application #208837

Application Sponsors

ANDA 208837

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

100MCG/VIAL

0

LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208837
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-27
        )

)