AMNEAL FDA Approval ANDA 214193

ANDA 214193

AMNEAL

FDA Drug Application

Application #214193

Application Sponsors

ANDA 214193AMNEAL

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION;OPHTHALMIC1%0PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE
002SOLUTION;OPHTHALMIC2%0PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE
003SOLUTION;OPHTHALMIC4%0PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT
002PrescriptionAT
003PrescriptionAT

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214193
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"2%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"4%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-21
        )

)

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