WES PHARMA INC FDA Approval ANDA 209069

ANDA 209069

WES PHARMA INC

FDA Drug Application

Application #209069

Application Sponsors

ANDA 209069WES PHARMA INC

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; ORIG1AP2020-07-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

WES PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209069
            [companyName] => WES PHARMA INC
            [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":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 2MG BASE;EQ 0.5MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE","submission":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","actionType":"EQ 8MG BASE;EQ 2MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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