MICRO LABS LTD INDIA FDA Approval ANDA 207401

ANDA 207401

MICRO LABS LTD INDIA

FDA Drug Application

Application #207401

Application Sponsors

ANDA 207401MICRO LABS LTD INDIA

Marketing Status

Prescription001

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL500MG0ACETAZOLAMIDEACETAZOLAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

MICRO LABS LTD INDIA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207401
            [companyName] => MICRO LABS LTD INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"500MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-01
        )

)

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