ANDA 207127

CEROVENE INC

FDA Drug Application

Application #207127

Documents

• Letter: 2020-03-18

Application Sponsors

ANDA 207127

CEROVENE INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

PYRIMETHAMINE

PYRIMETHAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

CEROVENE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207127
            [companyName] => CEROVENE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYRIMETHAMINE","activeIngredients":"PYRIMETHAMINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207127Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-28
        )

)