DR REDDYS FDA Approval ANDA 210214

ANDA 210214

DR REDDYS

FDA Drug Application

Application #210214

Application Sponsors

ANDA 210214DR REDDYS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;IV (INFUSION), SUBCUTANEOUS1MG/ML0TREPROSTINILTREPROSTINIL
002INJECTABLE;IV (INFUSION), SUBCUTANEOUS2.5MG/ML0TREPROSTINILTREPROSTINIL
003INJECTABLE;IV (INFUSION), SUBCUTANEOUS5MG/ML0TREPROSTINILTREPROSTINIL
004INJECTABLE;IV (INFUSION), SUBCUTANEOUS10MG/ML0TREPROSTINILTREPROSTINIL

FDA Submissions

UNKNOWN; ORIG1AP2020-05-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210214
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"1MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"10MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-22
        )

)

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