ANDA 215798

DR REDDYS

FDA Drug Application

Application #215798

Application Sponsors

ANDA 215798

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

POWDER;ORAL

500MG/PACKET

0

SAPROPTERIN DIHYDROCHLORIDE

SAPROPTERIN DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215798
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAPROPTERIN DIHYDROCHLORIDE","activeIngredients":"SAPROPTERIN DIHYDROCHLORIDE","strength":"500MG\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-13
        )

)