Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050777
Company: LEO PHARMA AS
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
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-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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-Package Insert, Labeling-Container/Carton Labels 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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

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 200744 FOUGERA PHARMS INC
TACROLIMUS TACROLIMUS 0.1% OINTMENT;TOPICAL Prescription No AB 210393 GLENMARK PHARMS LTD

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