Application 022185

Type: NDA
Sponsor: LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	SUSPENSION;TOPICAL	0.064%;0.005%	Yes	Yes
002	TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE	SUSPENSION;TOPICAL	0.064%;0.005%	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
N022185-001	TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022185-001	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	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`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	N022185-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022185-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022185-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022185-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022185-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022185-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022185-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022185-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022185-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022185-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022185-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022185-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022185-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022185-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022185-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022185-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022185-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022185-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022185-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022185-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022185-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022185-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022185-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022185-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022185-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022185-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022185-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022185-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022185-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022185-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022185-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022185-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022185-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022185-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022185-001	6753013	2020-01-27	U-193	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6753013	2020-01-27	U-88	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6753013	2020-01-27	U-1761	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6787529	2020-01-27	U-193	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6787529	2020-01-27	U-88	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6787529	2020-01-27	U-1761	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6753013	2020-01-27	U-193	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6753013	2020-01-27	U-88	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6753013	2020-01-27	U-1761	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6787529	2020-01-27	U-88	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6787529	2020-01-27	U-1761	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6787529	2020-01-27	U-193	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6753013	2020-01-27	U-193	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6753013	2020-01-27	U-88	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6753013	2020-01-27	U-1761	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6787529	2020-01-27	U-88	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6787529	2020-01-27	U-1761	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6787529	2020-01-27	U-193	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6753013	2020-01-27	U-193	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6753013	2020-01-27	U-88	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6753013	2020-01-27	U-1761	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6787529	2020-01-27	U-193	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6787529	2020-01-27	U-88	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6787529	2020-01-27	U-1761	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6753013	2020-01-27	U-193	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6753013	2020-01-27	U-88	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6753013	2020-01-27	U-1761	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6787529	2020-01-27	U-193	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6787529	2020-01-27	U-88	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6787529	2020-01-27	U-1761	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6753013	2020-01-27	U-193	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6753013	2020-01-27	U-1761	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6753013	2020-01-27	U-88	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6787529	2020-01-27	U-1761	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6787529	2020-01-27	U-193	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6787529	2020-01-27	U-88	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	NPP	2022-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	PED	2023-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022185-001	NPP	2022-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022185-001	PED	2023-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022185-001	NPP	2022-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022185-001	PED	2023-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022185-001	NPP	2022-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	PED	2023-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022185-001	NPP	2022-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022185-001	PED	2023-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022185-001	NPP	2022-07-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022185-001	PED	2023-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	NPP	2022-07-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	PED	2023-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022185-001	NPP	2022-07-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022185-001	PED	2023-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022185-001	NPP	2022-07-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	PED	2023-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	NPP	2022-07-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	PED	2023-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022185-001	NPP	2022-07-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	PED	2023-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022185-001	NPP	2022-07-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	PED	2023-01-25	`b00525d2431f…`
2023-12-20 04:57 UTC	2023-12	N022185-001	PED	2023-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022185-001	PED	2023-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022185-001	PED	2023-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022185-001	PED	2023-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022185-001	PED	2023-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022185-001	PED	2023-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022185-001	NPP	2022-07-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022185-001	PED	2023-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	NPP	2022-07-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	PED	2023-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022185-001	NPP	2022-07-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022185-001	PED	2023-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022185-001	NPP	2022-07-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022185-001	PED	2023-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022185-001	NPP	2022-07-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022185-001	PED	2023-01-25	`cb3db0bc1861…`

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
TACLONEX	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	LEO Pharma Inc.	757c914f-dd8d-43cc-a973-212d591af4af	2017-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022185 application number: NDA022185 ndc (product): 50222-501

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50222-501	TACLONEX	calcipotriene and betamethasone dipropionate	LEO Pharma Inc.	NDA	Current
50222-501	TACLONEX	calcipotriene and betamethasone dipropionate	LEO Pharma Inc.	NDA	Current
50222-501	TACLONEX	calcipotriene and betamethasone dipropionate	LEO Pharma Inc.	NDA	Current
50222-501	TACLONEX	calcipotriene and betamethasone dipropionate	LEO Pharma Inc.	NDA	Current
50222-501	TACLONEX	calcipotriene and betamethasone dipropionate	LEO Pharma Inc.	NDA	Current
66993-937	Calcipotriene and Betamethasone Dipropionate	Calcipotriene and Betamethasone Dipropionate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-937	Calcipotriene and Betamethasone Dipropionate	Calcipotriene and Betamethasone Dipropionate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59484	SUPPL	2019-07-29
57695	SUPPL	2019-02-19
38351	SUPPL	2016-06-23
38350	SUPPL	2015-11-04
38349	SUPPL	2014-09-03
29370	SUPPL	2014-09-03
29371	SUPPL	2014-07-29
17053	SUPPL	2014-07-29
38347	SUPPL	2013-11-19
38348	SUPPL	2013-11-08
29369	SUPPL	2013-11-08
7011	SUPPL	2013-11-08
17052	SUPPL	2012-12-04
7010	SUPPL	2012-12-04
29368	SUPPL	2012-10-22
38346	SUPPL	2012-10-18
21954	ORIG	2009-04-14
29367	SUPPL	2009-03-24
44695	ORIG	2008-07-17
29366	ORIG	2008-05-15
52076	SUPPL	1900-01-01
52075	SUPPL	1900-01-01
52074	SUPPL	1900-01-01