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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050777
Company: LEO PHARMA AS

Medication Guide

Other Important Information from FDA

Products on NDA 050777

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROTOPIC	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	AB	Yes	Yes
PROTOPIC	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050777

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50777lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50777ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50777_protopic.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2019	SUPPL-21	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050777s021lbl.pdf
11/04/2011	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050777s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050777s018ltr.pdf
12/31/2008	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050777s014ltr.pdf
01/19/2006	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050777s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05077s012ltr.pdf
07/14/2005	SUPPL-10	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050777s010ltr.pdf
12/23/2003	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scs006_protopic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scs006ltr.pdf
04/18/2003	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scp004_protopic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scp004ltr.pdf
11/22/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/2001	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 050777

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2019	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050777s021lbl.pdf
02/25/2019	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050777s021lbl.pdf
02/25/2019	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050777s021lbl.pdf
11/04/2011	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050777s018lbl.pdf
01/19/2006	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050777s012lbl.pdf
12/23/2003	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scs006_protopic_lbl.pdf
04/18/2003	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scp004_protopic_lbl.pdf
12/08/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50777lbl.pdf

Therapeutic Equivalents for NDA 050777

PROTOPIC

OINTMENT;TOPICAL; 0.03%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROTOPIC	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	Yes	AB	050777	LEO PHARMA AS
TACROLIMUS	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	No	AB	211688	ACCORD HLTHCARE
TACROLIMUS	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	No	AB	200744	FOUGERA PHARMS INC
TACROLIMUS	TACROLIMUS	0.03%	OINTMENT;TOPICAL	Prescription	No	AB	210393	GLENMARK PHARMS LTD

OINTMENT;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROTOPIC	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	Yes	AB	050777	LEO PHARMA AS
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	211688	ACCORD HLTHCARE
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	212387	ENCUBE
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	200744	FOUGERA PHARMS INC
TACROLIMUS	TACROLIMUS	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	210393	GLENMARK PHARMS LTD

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