ANDA 086557

COSETTE

FDA Drug Application

Application #086557

Application Sponsors

ANDA 086557

COSETTE

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;RECTAL

100MG;2MG

0

MIGERGOT

CAFFEINE; ERGOTAMINE TARTRATE

FDA Submissions

	ORIG	1	AP	1983-10-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-03-12
LABELING; Labeling	SUPPL	6	AP	1999-10-19
LABELING; Labeling	SUPPL	12	AP	2003-08-01
LABELING; Labeling	SUPPL	14	AP	2012-06-18
LABELING; Labeling	SUPPL	16	AP	2012-11-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	14	Null	15
SUPPL	16	Null	15

CDER Filings

COSETTE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86557
            [companyName] => COSETTE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIGERGOT","activeIngredients":"CAFFEINE; ERGOTAMINE TARTRATE","strength":"100MG;2MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIGERGOT","submission":"CAFFEINE; ERGOTAMINE TARTRATE","actionType":"100MG;2MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)