ANDA 210021

CADILA PHARMS LTD

FDA Drug Application

Application #210021

Application Sponsors

ANDA 210021

CADILA PHARMS LTD

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	2019-03-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-05-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210021
            [companyName] => CADILA PHARMS LTD
            [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\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-26
        )

)