NDA 021478

BAUSCH

FDA Drug Application

Application #021478

Documents

• Letter: 2004-07-01
• Letter: 2014-04-03
• Label: 2014-04-02
• Review: 2006-10-25
• Letter: 2004-02-02
• Label: 2003-04-09
• Review: 2003-07-08
• Review: 2018-04-18
• Label: 2020-12-28
• Letter: 2020-12-29

Application Sponsors

NDA 021478

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

5%

1

ZOVIRAX

ACYCLOVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2004-01-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-02-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-12-23	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	7	Null	6
SUPPL	8	Null	0
SUPPL	10	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21478
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOVIRAX","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/01\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021478s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21478_zovirax_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZOVIRAX","submission":"ACYCLOVIR","actionType":"5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-04-01
        )

)