ANDA 091118

SUN PHARM INDS LTD

FDA Drug Application

Application #091118

Application Sponsors

ANDA 091118

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001
• None (Tentative Approval): 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 55MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 65MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
007	TABLET, EXTENDED RELEASE;ORAL	EQ 115MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
008	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2014-09-25
	ORIG	2	AP	2019-12-03
	ORIG	3	TA	2019-12-03

Submissions Property Types

ORIG	1	Null	1
ORIG	2	Null	1
ORIG	3	Null	1

TE Codes

001	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB
008	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91118
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 45MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 55MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 65MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 80MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 90MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 105MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 115MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 135MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 45MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 55MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 65MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 80MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 90MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 105MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 115MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 135MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)