NDA 050584

BAUSCH

FDA Drug Application

Application #050584

Application Sponsors

NDA 050584

BAUSCH

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

2%

1

AKNE-MYCIN

ERYTHROMYCIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1985-01-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-02-28	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50584
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"AKNE-MYCIN","activeIngredients":"ERYTHROMYCIN","strength":"2%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AKNE-MYCIN","submission":"ERYTHROMYCIN","actionType":"2%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)