WES PHARMA INC FDA Approval ANDA 207509

ANDA 207509

WES PHARMA INC

FDA Drug Application

Application #207509

Application Sponsors

ANDA 207509WES PHARMA INC

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; ORIG1AP2018-10-29STANDARD
LABELING; LabelingSUPPL2AP2019-10-11STANDARD
LABELING; LabelingSUPPL4AP2021-03-04STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL4Null31

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

WES PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207509
            [companyName] => WES PHARMA INC
            [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":"10\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/11\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","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.