RHODES PHARMS FDA Approval ANDA 202991

ANDA 202991

RHODES PHARMS

FDA Drug Application

Application #202991

Application Sponsors

ANDA 202991RHODES PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL325MG;5MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE
002TABLET;ORAL325MG;7.5MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE
003TABLET;ORAL325MG;10MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2016-04-12
LABELING; LabelingSUPPL2AP2017-04-11STANDARD
REMS; REMSSUPPL4AP2018-09-18
LABELING; LabelingSUPPL5AP2018-09-21STANDARD
LABELING; LabelingSUPPL6AP2019-10-11STANDARD
LABELING; LabelingSUPPL8AP2021-03-04STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL4Null15
SUPPL5Null7
SUPPL6Null7
SUPPL8Null7

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

RHODES PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202991
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/21\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-4","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/11\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-11
        )

)

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