ANDA 213798

RUBICON

FDA Drug Application

Application #213798

Application Sponsors

ANDA 213798

RUBICON

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

2020-05-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213798
            [companyName] => RUBICON
            [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":"05\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-27
        )

)