HETERO LABS LTD III FDA Approval ANDA 091240

ANDA 091240

HETERO LABS LTD III

FDA Drug Application

Application #091240

Application Sponsors

ANDA 091240HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL25MG0INDOMETHACININDOMETHACIN
002CAPSULE;ORAL50MG0INDOMETHACININDOMETHACIN

FDA Submissions

ORIG1AP2011-04-12
LABELING; LabelingSUPPL3AP2021-04-26STANDARD
LABELING; LabelingSUPPL9AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15
SUPPL9Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91240
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"INDOMETHACIN","submission":"INDOMETHACIN","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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