ANDA 209920

TEVA PHARMS USA INC

FDA Drug Application

Application #209920

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 209920

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	8MCG	0	LUBIPROSTONE	LUBIPROSTONE
002	CAPSULE;ORAL	24MCG	0	LUBIPROSTONE	LUBIPROSTONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209920
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"8MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"24MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209920Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-18
        )

)