ANDA 075523

SUN PHARM INDS LTD

FDA Drug Application

Application #075523

Documents

• Review: 2000-03-17
• Letter: 2000-03-17
• Other: 2018-05-01

Application Sponsors

ANDA 075523

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 0.5MG BASE;EQ 50MG BASE

0

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-03-17
LABELING; Labeling	SUPPL	2	AP	2017-03-31	STANDARD
REMS; REMS	SUPPL	3	AP	2018-09-18
LABELING; Labeling	SUPPL	4	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75523
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE","strength":"EQ 0.5MG BASE;EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE","submission":"NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE;EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)