ANDA 207487

ABHAI LLC

FDA Drug Application

Application #207487

Documents

• Letter: 2017-03-02

Application Sponsors

ANDA 207487

ABHAI LLC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

1.5MG/5ML;5MG/5ML

0

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-02-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

ABHAI LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207487
            [companyName] => ABHAI LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG\/5ML;5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207487Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/05\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-07-05
        )

)