ANDA 215105

AMNEAL

FDA Drug Application

Application #215105

Application Sponsors

ANDA 215105

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.042MG/SPRAY

0

IPRATROPIUM BROMIDE

IPRATROPIUM BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215105
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IPRATROPIUM BROMIDE","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.042MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-16
        )

)