RHODES PHARMS FDA Approval ANDA 207276

ANDA 207276

RHODES PHARMS

FDA Drug Application

Application #207276

Documents

REMS2017-10-12

Application Sponsors

ANDA 207276RHODES PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;SUBLINGUALEQ 2MG BASE0BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE
002TABLET;SUBLINGUALEQ 8MG BASE0BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-03-27STANDARD
LABELING; LabelingSUPPL3AP2018-02-01STANDARD
REMS; REMSSUPPL4AP2018-10-31
LABELING; LabelingSUPPL8AP2021-03-04STANDARD
LABELING; LabelingSUPPL10AP2022-06-13STANDARD
LABELING; LabelingSUPPL11AP2022-06-17STANDARD
REMS; REMSSUPPL12AP2022-05-03
LABELING; LabelingSUPPL13AP2022-06-17STANDARD
REMS; REMSSUPPL14AP2022-12-16

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL4Null7
SUPPL8Null15
SUPPL10Null15
SUPPL11Null7
SUPPL12Null7
SUPPL13Null7
SUPPL14Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

RHODES PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207276
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/31\/2018","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/01\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/23\/2017","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-10-31
        )

)

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