ANDA 080426

BAUSCH

FDA Drug Application

Application #080426

Application Sponsors

ANDA 080426

BAUSCH

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	LOTION;TOPICAL	1%	0	CETACORT	HYDROCORTISONE
002	LOTION;TOPICAL	0.5%	0	CETACORT	HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1971-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-04-23
LABELING; Labeling	SUPPL	9	AP	1992-03-18
LABELING; Labeling	SUPPL	10	AP	1994-07-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-10-20

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80426
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETACORT","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CETACORT","activeIngredients":"HYDROCORTISONE","strength":"0.5%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CETACORT","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CETACORT","submission":"HYDROCORTISONE","actionType":"0.5%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)