HIKMA INTL PHARMS FDA Approval ANDA 206617

ANDA 206617

HIKMA INTL PHARMS

FDA Drug Application

Application #206617

Application Sponsors

ANDA 206617HIKMA INTL PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 200MG BASE/VIAL0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HIKMA INTL PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206617
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 200MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-25
        )

)

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