ANDA 091502

MYLAN PHARMS INC

FDA Drug Application

Application #091502

Application Sponsors

ANDA 091502

MYLAN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	EQ 2MG BASE	0	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 4MG BASE	0	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 6MG BASE	0	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-11-09
LABELING; Labeling	SUPPL	3	AP	2021-10-20	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91502
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 6MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)