CIPLA FDA Approval ANDA 078759

ANDA 078759

CIPLA

FDA Drug Application

Application #078759

Application Sponsors

ANDA 078759CIPLA

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

ORIG1AP2011-07-25
LABELING; LabelingSUPPL2AP2016-06-23STANDARD
LABELING; LabelingSUPPL3AP2019-05-03STANDARD
LABELING; LabelingSUPPL4AP2019-05-03STANDARD
LABELING; LabelingSUPPL5AP2019-05-03STANDARD
LABELING; LabelingSUPPL6AP2019-10-17STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7
SUPPL4Null7
SUPPL5Null7
SUPPL6Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

CIPLA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78759
            [companyName] => CIPLA
            [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":"GEMCITABINE HYDROCHLORIDE","submission":"GEMCITABINE HYDROCHLORIDE","actionType":"EQ 200MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GEMCITABINE HYDROCHLORIDE","submission":"GEMCITABINE HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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