NDA 050777

LEO PHARMA AS

FDA Drug Application

Application #050777

Documents

• Letter: 2003-05-29
• Letter: 2003-12-24
• Letter: 2009-01-06
• Label: 2003-04-07
• Label: 2003-05-29
• Review: 2003-04-22
• Other Important Information from FDA: 2005-04-15
• Letter: 2003-04-09
• Letter: 2005-07-15
• Letter: 2006-01-30
• Letter: 2011-11-08
• Label: 2003-12-29
• Label: 2006-01-19
• Label: 2011-11-17
• Medication Guide: 2006-01-19
• Label: 2022-08-09
• Medication Guide: 2022-08-09

Application Sponsors

NDA 050777

LEO PHARMA AS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	OINTMENT;TOPICAL	0.03%	1	PROTOPIC	TACROLIMUS
002	OINTMENT;TOPICAL	0.1%	1	PROTOPIC	TACROLIMUS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2003-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2003-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2005-07-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2006-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2008-12-31	N/A
LABELING; Labeling	SUPPL	18	AP	2011-11-04	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2019-02-25	N/A

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	18	Null	15
SUPPL	21	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50777
            [companyName] => LEO PHARMA AS
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088996.pdf"]
            [products] => [{"drugName":"PROTOPIC","activeIngredients":"TACROLIMUS","strength":"0.03%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"PROTOPIC","activeIngredients":"TACROLIMUS","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/04\/2011","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050777s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2006","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/050777s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2003","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50777scs006_protopic_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"04\/18\/2003","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50777scp004_protopic_lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/50777lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROTOPIC","submission":"TACROLIMUS","actionType":"0.03%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROTOPIC","submission":"TACROLIMUS","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-11-04
        )

)