ANDA 208987

SUNSHINE LAKE

FDA Drug Application

Application #208987

Application Sponsors

ANDA 208987

SUNSHINE LAKE

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

500MG

0

CLARITHROMYCIN

CLARITHROMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

SUNSHINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208987
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-09
        )

)