ANDA 205055

ALVOGEN

FDA Drug Application

Application #205055

Documents

• Letter: 2015-12-16

Application Sponsors

ANDA 205055

ALVOGEN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	60MG	0	NATEGLINIDE	NATEGLINIDE
002	TABLET;ORAL	120MG	0	NATEGLINIDE	NATEGLINIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-12-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205055
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NATEGLINIDE","activeIngredients":"NATEGLINIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NATEGLINIDE","activeIngredients":"NATEGLINIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205055Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/03\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-12-03
        )

)