BEXIMCO PHARMS USA FDA Approval ANDA 215466

ANDA 215466

BEXIMCO PHARMS USA

FDA Drug Application

Application #215466

Application Sponsors

ANDA 215466BEXIMCO PHARMS USA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 50MG BASE0MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDE
002TABLET;ORALEQ 75MG BASE0MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDE
003TABLET;ORALEQ 100MG BASE0MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BEXIMCO PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215466
            [companyName] => BEXIMCO PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-27
        )

)

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