ANDA 204453

ALKEM LABS LTD

FDA Drug Application

Application #204453

Documents

• Letter: 2018-04-05

Application Sponsors

ANDA 204453

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 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 80MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	EQ 65MG 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 55MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-09-28
UNKNOWN;	ORIG	2	AP	2018-03-16
UNKNOWN;	ORIG	3	AP	2019-12-19

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	19
ORIG	3	Null	7

TE Codes

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

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204453
            [companyName] => ALKEM LABS 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 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 135MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","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 115MG 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":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2019","submission":"ORIG-3","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/16\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204453Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-19
        )

)