TWI PHARMS FDA Approval ANDA 217054

ANDA 217054

TWI PHARMS

FDA Drug Application

Application #217054

Application Sponsors

ANDA 217054TWI PHARMS

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL10MG0DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-12-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

TWI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 217054
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-27
        )

)

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