ANDA 080442

BAUSCH

FDA Drug Application

Application #080442

Application Sponsors

ANDA 080442

BAUSCH

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	CREAM;TOPICAL	0.5%	0	NUTRACORT	HYDROCORTISONE
003	CREAM;TOPICAL	1%	0	NUTRACORT	HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1972-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1982-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1984-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1984-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1984-07-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1984-07-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1985-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1985-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1985-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1985-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1985-11-15
LABELING; Labeling	SUPPL	46	AP	1991-02-01
LABELING; Labeling	SUPPL	47	AP	1994-04-25

Submissions Property Types

SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	38	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	44	Null	0

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80442
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUTRACORT","activeIngredients":"HYDROCORTISONE","strength":"0.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NUTRACORT","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NUTRACORT","submission":"HYDROCORTISONE","actionType":"0.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NUTRACORT","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)