SUN PHARM INDUSTRIES FDA Approval ANDA 214737

ANDA 214737

SUN PHARM INDUSTRIES

FDA Drug Application

Application #214737

Application Sponsors

ANDA 214737SUN PHARM INDUSTRIES

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006

Application Products

002TABLET;SUBLINGUALEQ 5.7MG BASE;EQ 1.4MG BASE00BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
003TABLET;SUBLINGUALEQ 8.6MG BASE;EQ 2.1MG BASE00BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
004TABLET;SUBLINGUALEQ 11.4MG BASE;EQ 2.9MG BASE00BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
005TABLET;SUBLINGUALEQ 2.9MG BASE;EQ 0.71MG BASE00BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
006TABLET;SUBLINGUALEQ 0.7MG BASE;EQ 0.18MG BASE00BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-01-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SUN PHARM INDUSTRIES
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(
    [0] => Array
        (
            [ApplNo] => 214737
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 1.4MG BASE;EQ 0.36MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 5.7MG BASE;EQ 1.4MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 8.6MG BASE;EQ 2.1MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 11.4MG BASE;EQ 2.9MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 2.9MG BASE;EQ 0.71MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","strength":"EQ 0.7MG BASE;EQ 0.18MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-19
        )

)

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