SUN PHARM INDUSTRIES FDA Approval ANDA 090217

ANDA 090217

SUN PHARM INDUSTRIES

FDA Drug Application

Application #090217

Application Sponsors

ANDA 090217SUN PHARM INDUSTRIES

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

ORIG1AP2016-01-29

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUN PHARM INDUSTRIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90217
            [companyName] => SUN PHARM INDUSTRIES
            [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":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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