NDA 021385

BAUSCH

FDA Drug Application

Application #021385

Documents

• Letter: 2005-11-30
• Letter: 2014-01-23
• Letter: 2003-12-16
• Label: 2003-12-10
• Label: 2014-01-23
• Review: 2004-03-08
• Label: 2020-12-17
• Letter: 2020-12-21

Application Sponsors

NDA 021385

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

2%

1

ERTACZO

SERTACONAZOLE NITRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2003-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2005-11-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-01-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-12-17	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	7
SUPPL	6	Null	15

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21385
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERTACZO","activeIngredients":"SERTACONAZOLE NITRATE","strength":"2%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/22\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021385s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21385_Ertaczo_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ERTACZO","submission":"SERTACONAZOLE NITRATE","actionType":"2%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-01-22
        )

)