MICRO LABS FDA Approval ANDA 207402

ANDA 207402

MICRO LABS

FDA Drug Application

Application #207402

Application Sponsors

ANDA 207402MICRO LABS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 75MG BASE0CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDE
002CAPSULE;ORALEQ 150MG BASE0CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDE
003CAPSULE;ORALEQ 300MG BASE0CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-11-05STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207402
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-05
        )

)

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