ANDA 207609

HI TECH

FDA Drug Application

Application #207609

Documents

• Letter: 2019-05-21

Application Sponsors

ANDA 207609

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.5%

0

LOTEPREDNOL ETABONATE

LOTEPREDNOL ETABONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HI TECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207609
            [companyName] => HI TECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEPREDNOL ETABONATE","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.5%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207609Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-17
        )

)