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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020554
Company: LEO PHARMA AS

Products on NDA 020554

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOVONEX	CALCIPOTRIENE	0.005%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020554

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2025	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020273s015,020554s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020273Orig1s015,020554Orig1s013ltr.pdf
03/11/2015	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf
11/21/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/14/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/12/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/26/2007	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf
04/28/2005	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020554s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020554s006ltr.pdf
03/23/2001	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/11/2000	SUPPL-4	Labeling		Label is not available on this site.
03/11/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/18/1998	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020554

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020273s015,020554s013lbl.pdf
03/11/2015	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf
09/26/2007	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf
04/28/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020554s006lbl.pdf

Therapeutic Equivalents for NDA 020554

DOVONEX

CREAM;TOPICAL; 0.005%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	CREAM;TOPICAL	Prescription	No	AB	205772	GLENMARK SPECLT
DOVONEX	CALCIPOTRIENE	0.005%	CREAM;TOPICAL	Prescription	Yes	AB	020554	LEO PHARMA AS

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