ANDA 208038

US GENERICS, STERILES

FDA Drug Application

Application #208038

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 208038

US GENERICS, STERILES

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001

SOLUTION;SUBCUTANEOUS

12MG/0.6ML

0

METHYLNALTREXONE BROMIDE

METHYLNALTREXONE BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-08-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

US GENERICS, STERILES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208038
            [companyName] => US GENERICS, STERILES
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLNALTREXONE BROMIDE","activeIngredients":"METHYLNALTREXONE BROMIDE","strength":"12MG\/.4ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLNALTREXONE BROMIDE","activeIngredients":"METHYLNALTREXONE BROMIDE","strength":"8MG","dosageForm":"SOLUTION; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLNALTREXONE BROMIDE","activeIngredients":"METHYLNALTREXONE BROMIDE","strength":"12MG","dosageForm":"SOLUTION; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208038Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-12
        )

)