ANDA 210395

ZYDUS PHARMS

FDA Drug Application

Application #210395

Application Sponsors

ANDA 210395

ZYDUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	10MEQ	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	20MEQ	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB1
002	Prescription	AB1

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210395
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-17
        )

)