NDA 021302

BAUSCH

FDA Drug Application

Application #021302

Documents

• Letter: 2001-12-13
• Letter: 2006-01-30
• Letter: 2007-08-14
• Letter: 2014-04-02
• Label: 2004-12-03
• Label: 2007-08-14
• Label: 2014-04-01
• Letter: 2003-10-17
• Letter: 2004-12-02
• Letter: 2010-07-23
• Label: 2001-12-13
• Label: 2003-10-17
• Label: 2006-01-19
• Label: 2010-07-22
• Review: 2001-12-13
• Medication Guide: 2011-01-13

Application Sponsors

NDA 021302

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

1

ELIDEL

PIMECROLIMUS

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2001-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2003-10-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2004-11-24	STANDARD
LABELING; Labeling	SUPPL	11	AP	2006-01-19	STANDARD
LABELING; Labeling	SUPPL	12	AP	2007-08-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2007-09-14	N/A
LABELING; Labeling	SUPPL	14	AP	2010-07-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2014-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2014-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2016-06-09	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	0
SUPPL	14	Null	6
SUPPL	18	Null	6
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21302
            [companyName] => BAUSCH
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088587.pdf"]
            [products] => [{"drugName":"ELIDEL","activeIngredients":"PIMECROLIMUS","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/28\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021302s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2010","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021302s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2007","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021302s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2006","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021302s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2004","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21302s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2003","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21302scp004_elidel_lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21302lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ELIDEL","submission":"PIMECROLIMUS","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-03-28
        )

)