ANDA 209356

AMNEAL PHARMS LLC

FDA Drug Application

Application #209356

Documents

• Letter: 2020-03-17
• Review: 2019-12-02

Application Sponsors

ANDA 209356

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

1GM/10ML

0

SUCRALFATE

SUCRALFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209356
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCRALFATE","activeIngredients":"SUCRALFATE","strength":"1GM\/10ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209356Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209356Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-02
        )

)