ANDA 215961

DR REDDYS

FDA Drug Application

Application #215961

Application Sponsors

ANDA 215961

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.004MG/ML

0

DESMOPRESSIN ACETATE

DESMOPRESSIN ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215961
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESMOPRESSIN ACETATE","activeIngredients":"DESMOPRESSIN ACETATE","strength":"0.004MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-19
        )

)