ANDA 206214

MARKSANS PHARMA

FDA Drug Application

Application #206214

Documents

• Letter: 2016-09-27
• Label: 2016-10-12

Application Sponsors

ANDA 206214

MARKSANS PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

10MG

0

LORATADINE

LORATADINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

MARKSANS PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206214
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/23\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206214Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206214Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206214Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-09-23
        )

)