ANDA 204227

SANDOZ INC

FDA Drug Application

Application #204227

Documents

• Letter: 2016-07-13

Application Sponsors

ANDA 204227

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

GATIFLOXACIN

GATIFLOXACIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-07-11

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204227
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GATIFLOXACIN","activeIngredients":"GATIFLOXACIN","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204227Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-23
        )

)