ANDA 210088

SUN PHARM

FDA Drug Application

Application #210088

Documents

• Letter: 2018-05-11

Application Sponsors

ANDA 210088

SUN PHARM

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, CHEWABLE;ORAL

5MG

0

LORATADINE

LORATADINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-03-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	7

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210088
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210088Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-05
        )

)