Application 020273

Type: NDA
Sponsor: LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOVONEX	CALCIPOTRIENE	OINTMENT;TOPICAL	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020273-001	DOVONEX	CALCIPOTRIENE	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020273-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020273-001	DOVONEX	0.005%	OINTMENT / TOPICAL		RLD	1993-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020273-001	DOVONEX	0.005%	OINTMENT / TOPICAL		RLD	1993-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020273-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020273-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020273-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020273-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020273-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020273-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020273-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020273-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020273-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020273-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020273-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020273-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020273-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020273-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020273-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020273-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020273-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020273-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020273-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020273-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020273-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020273-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020273-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020273-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020273-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020273-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020273-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
calcipotriene	CALCIPOTRIENE	Prasco Laboratories	fe7cd92a-f066-4c4a-80c8-e3f929ad4181	2020-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020273 application number: NDA020273 ndc (product): 66993-878

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66993-878	calcipotriene	calcipotriene	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-878	calcipotriene	calcipotriene	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-878	calcipotriene	calcipotriene	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-878	calcipotriene	calcipotriene	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-878	calcipotriene	calcipotriene	Prasco Laboratories	NDA AUTHORIZED	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83681	SUPPL	2025-10-07
83671	SUPPL	2025-10-06
12410	SUPPL	2015-03-17
2285	SUPPL	2015-03-13
41263	SUPPL	2009-01-12
12409	SUPPL	2007-10-04
2284	SUPPL	2007-10-04
34461	SUPPL	2005-05-02
24715	SUPPL	2005-05-02
20582	SUPPL	1999-07-07
2283	SUPPL	1999-07-07