ABHAI LLC FDA Approval ANDA 209036

ANDA 209036

ABHAI LLC

FDA Drug Application

Application #209036

Application Sponsors

ANDA 209036ABHAI LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL300MG;5MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE
002TABLET;ORAL300MG;7.5MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE
003TABLET;ORAL300MG;10MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2017-06-21STANDARD
LABELING; LabelingSUPPL2AP2018-09-20STANDARD
LABELING; LabelingSUPPL3AP2019-10-11STANDARD
LABELING; LabelingSUPPL5AP2021-03-05STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null7
SUPPL5Null15

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

ABHAI LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209036
            [companyName] => ABHAI LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"300MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"300MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"300MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-1","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-11
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.