NDA 216264

PROVEPHARM SAS

FDA Drug Application

Application #216264

Documents

• Letter: 2022-07-11
• Label: 2022-07-11

Application Sponsors

NDA 216264

PROVEPHARM SAS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; INJECTION

40MG/5ML

0

BLUDIGO

INDIGOTINDISULFONATE SODIUM

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA

ORIG

1

AP

2022-07-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PROVEPHARM SAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216264
            [companyName] => PROVEPHARM SAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BLUDIGO","activeIngredients":"INDIGOTINDISULFONATE SODIUM","strength":"40MG\/5ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/08\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216264s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216264s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216264Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-07-08
        )

)