ANDA 200889

SANDOZ INC

FDA Drug Application

Application #200889

Documents

• Letter: 2012-08-06

Application Sponsors

ANDA 200889

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

MONTELUKAST SODIUM

MONTELUKAST SODIUM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-08-03
LABELING; Labeling	SUPPL	4	AP	2013-01-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-06-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-05-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-05-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2018-07-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-10-01	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-09-04	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-09-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-01-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200889
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200889Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/01\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/26\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/04\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/04\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2013","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/31\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-01
        )

)