ANDA 214395

AMTA

FDA Drug Application

Application #214395

Application Sponsors

ANDA 214395

AMTA

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

2021-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB1
002	Prescription	AB1

CDER Filings

AMTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214395
            [companyName] => AMTA
            [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":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"10MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"20MEQ","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)