ANDA 214760

AMTA

FDA Drug Application

Application #214760

Application Sponsors

ANDA 214760

AMTA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

60MG

0

TROSPIUM CHLORIDE

TROSPIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214760
            [companyName] => AMTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TROSPIUM CHLORIDE","activeIngredients":"TROSPIUM CHLORIDE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-30
        )

)