ANDA 062687

MLV

FDA Drug Application

Application #062687

Application Sponsors

ANDA 062687

MLV

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;TOPICAL

2%

0

ERYTHRA-DERM

ERYTHROMYCIN

FDA Submissions

	ORIG	1	AP	1988-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-01-14
LABELING; Labeling	SUPPL	3	AP	1993-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-02-11

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0

TE Codes

001

Prescription

AT

CDER Filings

SAPTALIS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62687
            [companyName] => SAPTALIS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHRA-DERM","activeIngredients":"ERYTHROMYCIN","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERYTHRA-DERM","submission":"ERYTHROMYCIN","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)