ANDA 210610

UPSHER SMITH LABS

FDA Drug Application

Application #210610

Documents

• Letter: 2019-08-07

Application Sponsors

ANDA 210610

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	15MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	TABLET;ORAL	30MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210610
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210610Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-22
        )

)