ANDA 214737

SUN PHARM INDUSTRIES

FDA Drug Application

Application #214737

Application Sponsors

ANDA 214737

SUN 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

001	TABLET;SUBLINGUAL	EQ 1.4MG BASE;EQ 0.36MG BASE	0	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
002	TABLET;SUBLINGUAL	EQ 5.7MG BASE;EQ 1.4MG BASE	0	0	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
003	TABLET;SUBLINGUAL	EQ 8.6MG BASE;EQ 2.1MG BASE	0	0	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
004	TABLET;SUBLINGUAL	EQ 11.4MG BASE;EQ 2.9MG BASE	0	0	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
005	TABLET;SUBLINGUAL	EQ 2.9MG BASE;EQ 0.71MG BASE	0	0	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
006	TABLET;SUBLINGUAL	EQ 0.7MG BASE;EQ 0.18MG BASE	0	0	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-01-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [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
        )

)