RHODES PHARMS FDA Approval ANDA 205601

ANDA 205601

RHODES PHARMS

FDA Drug Application

Application #205601

Application Sponsors

ANDA 205601RHODES PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASE0BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
002TABLET;SUBLINGUALEQ 8MG BASE;EQ 2MG BASE0BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-03-30STANDARD
LABELING; LabelingSUPPL6AP2022-06-13STANDARD
LABELING; LabelingSUPPL7AP2022-06-17STANDARD
REMS; REMSSUPPL8AP2022-05-03
LABELING; LabelingSUPPL11AP2022-06-17STANDARD
REMS; REMSSUPPL13AP2022-12-16

Submissions Property Types

ORIG1Null15
SUPPL6Null7
SUPPL7Null15
SUPPL8Null15
SUPPL11Null7
SUPPL13Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

RHODES PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205601
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2MG BASE;EQ 0.5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8MG BASE;EQ 2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-30
        )

)

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