ANDA 206939

BELCHER

FDA Drug Application

Application #206939

Documents

• Label: 2017-02-08
• Letter: 2017-02-08

Application Sponsors

ANDA 206939

BELCHER

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

500MG/5ML

0

CEFIXIME

CEFIXIME

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-02-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

BELCHER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206939
            [companyName] => BELCHER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFIXIME","activeIngredients":"CEFIXIME","strength":"500MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/06\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206939Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206939Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206939Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-02-06
        )

)