ANDA 213003

ZYDUS PHARMS

FDA Drug Application

Application #213003

Application Sponsors

ANDA 213003

ZYDUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.125MG	0	TRIAZOLAM	TRIAZOLAM
002	TABLET;ORAL	0.25MG	0	TRIAZOLAM	TRIAZOLAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213003
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAZOLAM","activeIngredients":"TRIAZOLAM","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAZOLAM","activeIngredients":"TRIAZOLAM","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-28
        )

)