ANDA 211204

AMNEAL PHARMS

FDA Drug Application

Application #211204

Application Sponsors

ANDA 211204

AMNEAL PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GRANULE;ORAL	EQ 200MG BASE/5ML	0	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE
002	GRANULE;ORAL	EQ 400MG BASE/5ML	0	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211204
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 200MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 400MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-01
        )

)