ECI PHARMS LLC FDA Approval ANDA 213530

ANDA 213530

ECI PHARMS LLC

FDA Drug Application

Application #213530

Application Sponsors

ANDA 213530ECI PHARMS LLC

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL5MG;2.5MG0CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDECHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ECI PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213530
            [companyName] => ECI PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE","activeIngredients":"CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE","strength":"5MG;2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-21
        )

)

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