NDA 022076

BAUSCH

FDA Drug Application

Application #022076

Documents

• Letter: 2007-05-29
• Letter: 2014-10-31
• Label: 2007-05-29
• Review: 2009-12-17
• Label: 2014-11-04

Application Sponsors

NDA 022076

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.1%

1

LOCOID

HYDROCORTISONE BUTYRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2007-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2013-11-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-10-30	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22076
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOCOID","activeIngredients":"HYDROCORTISONE BUTYRATE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/30\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022076s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022076lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOCOID","submission":"HYDROCORTISONE BUTYRATE","actionType":"0.1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-10-30
        )

)