ANDA 074454

COSETTE

FDA Drug Application

Application #074454

Application Sponsors

ANDA 074454

COSETTE

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

EQ 2MG BASE/5ML

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	1995-09-25
LABELING; Labeling	SUPPL	2	AP	1999-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-07-07
LABELING; Labeling	SUPPL	4	AP	1999-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-07-07
LABELING; Labeling	SUPPL	6	AP	1999-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-12-03
LABELING; Labeling	SUPPL	30	AP	2015-06-10

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	30	Null	15

TE Codes

001

Prescription

AA

CDER Filings

COSETTE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74454
            [companyName] => COSETTE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 2MG BASE\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 2MG BASE\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)