ALEMBIC PHARMS LTD FDA Approval ANDA 211935

ANDA 211935

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211935

Application Sponsors

ANDA 211935ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL25MG0NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE
002CAPSULE;ORAL50MG0NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE
003CAPSULE;ORAL100MG0NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211935
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","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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