ANDA 203411

SANDOZ INC

FDA Drug Application

Application #203411

Documents

• Letter: 2014-04-04

Application Sponsors

ANDA 203411

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

400MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-04-03
LABELING; Labeling	SUPPL	4	AP	2019-08-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-08-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-11-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203411
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203411Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/29\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-29
        )

)