ANDA 091414

SANDOZ INC

FDA Drug Application

Application #091414

Documents

• Letter: 2012-08-06

Application Sponsors

ANDA 091414

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, CHEWABLE;ORAL	EQ 4MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM
002	TABLET, CHEWABLE;ORAL	EQ 5MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM

FDA Submissions

	ORIG	1	AP	2012-08-03
LABELING; Labeling	SUPPL	4	AP	2013-01-28	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	14	AP	2020-09-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-09-04	STANDARD
LABELING; Labeling	SUPPL	17	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	7
SUPPL	14	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91414
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 4MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 5MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)