ANDA 209758

TEVA PHARMS USA INC

FDA Drug Application

Application #209758

Application Sponsors

ANDA 209758

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MEQ	0	POTASSIUM CITRATE	POTASSIUM CITRATE
002	TABLET, EXTENDED RELEASE;ORAL	10MEQ	0	POTASSIUM CITRATE	POTASSIUM CITRATE
003	TABLET, EXTENDED RELEASE;ORAL	15MEQ	0	POTASSIUM CITRATE	POTASSIUM CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209758
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"5MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"15MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-05
        )

)