ANDA 089440

GENUS

FDA Drug Application

Application #089440

Application Sponsors

ANDA 089440

GENUS

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;TOPICAL

1%;1%

0

HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-05-17
LABELING; Labeling	SUPPL	2	AP	1998-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-08-11

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

GENUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89440
            [companyName] => GENUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%","activeIngredients":"HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE","strength":"1%;1%","dosageForm":"AEROSOL, METERED;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%","submission":"HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE","actionType":"1%;1%","submissionClassification":"AEROSOL, METERED;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)