ANDA 207176

AVANTHI INC

FDA Drug Application

Application #207176

Application Sponsors

ANDA 207176

AVANTHI INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1.5MG;5MG

0

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

AVANTHI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207176
            [companyName] => AVANTHI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/05\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-07-05
        )

)