ANDA 208622

ZYDUS PHARMS

FDA Drug Application

Application #208622

Application Sponsors

ANDA 208622

ZYDUS PHARMS

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

UNKNOWN;	ORIG	1	AP	2017-03-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-05-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208622
            [companyName] => ZYDUS PHARMS
            [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":"03\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-03
        )

)