ACCORD HLTHCARE FDA Approval ANDA 205379

ANDA 205379

ACCORD HLTHCARE

FDA Drug Application

Application #205379

Documents

Label2015-11-25
Letter2015-10-02

Application Sponsors

ANDA 205379ACCORD HLTHCARE

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUSEQ 40MG BASE/VIAL0ESOMEPRAZOLE SODIUMESOMEPRAZOLE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2015-09-25STANDARD
LABELING; LabelingSUPPL2AP2020-04-17STANDARD
LABELING; LabelingSUPPL3AP2020-04-17STANDARD
LABELING; LabelingSUPPL4AP2020-04-17STANDARD
LABELING; LabelingSUPPL6AP2020-04-17STANDARD
LABELING; LabelingSUPPL7AP2020-04-17STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7
SUPPL4Null7
SUPPL6Null7
SUPPL7Null7

TE Codes

001PrescriptionAP

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205379
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/25\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205379Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/25\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205379Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205379Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/17\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-17
        )

)

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