ANDA 213628

ORANGE

FDA Drug Application

Application #213628

Application Sponsors

ANDA 213628

ORANGE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	ERYTHROMYCIN	ERYTHROMYCIN
002	TABLET;ORAL	500MG	0	ERYTHROMYCIN	ERYTHROMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ORANGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213628
            [companyName] => ORANGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-28
        )

)