ANDA 090911

MYLAN PHARMS INC

FDA Drug Application

Application #090911

Documents

• Label: 2010-07-22

Application Sponsors

ANDA 090911

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	0	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-07-20
LABELING; Labeling	SUPPL	2	AP	2012-06-05
LABELING; Labeling	SUPPL	3	AP	2016-04-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90911
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 45MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 90MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 135MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/20\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/090911s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 45MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 90MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 135MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-07-20
        )

)