ZYDUS PHARMS USA INC FDA Approval ANDA 214264

ANDA 214264

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214264

Documents

Letter2021-09-02

Application Sponsors

ANDA 214264ZYDUS PHARMS USA INC

Marketing Status

None (Tentative Approval)001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 11MG BASE0TOFACITINIBTOFACITINIB CITRATE
002TABLET, EXTENDED RELEASE;ORALEQ 22MG BASE0TOFACITINIBTOFACITINIB CITRATE

FDA Submissions

UNKNOWN; ORIG1TA2020-10-16STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214264
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-16
        )

)

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