ANDA 202308

SANDOZ INC

FDA Drug Application

Application #202308

Documents

• Letter: 2014-02-26

Application Sponsors

ANDA 202308

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION; OPHTHALMIC

1%

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

ORIG

1

TA

2014-02-24

Submissions Property Types

ORIG

1

Null

3

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202308
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"1%","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/24\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202308Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-02-24
        )

)