Application 203567

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JUBLIA	EFINACONAZOLE	SOLUTION;TOPICAL	10%	Yes	Yes

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
N203567-001	JUBLIA	EFINACONAZOLE	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203567-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203567-001	7214506	2026-02-22	U-281		2014-06-20
N203567-001	10512640	2028-01-03	U-1969		2020-01-08
N203567-001	10828369	2028-01-03		Drug product	2020-12-02
N203567-001	11213519	2028-01-03	U-2720		2022-01-20
N203567-001	11872218	2028-01-03	U-1969		2024-02-09
N203567-001	9566272	2028-01-03	U-1969		2017-02-22
N203567-001	9877955	2028-01-03	U-1969		2018-01-31
N203567-001	10105444	2030-07-08		Drug product	2018-10-24
N203567-001	8039494	2030-07-08	U-281		2014-06-20
N203567-001	9861698	2030-07-08		Drug product	2018-01-10
N203567-001	8486978	2030-10-24		Drug product	2014-06-20
N203567-001	9302009	2030-10-24		Drug product	2016-04-25
N203567-001	10342875	2034-10-02	U-2720	Drug product	2019-07-12
N203567-001	10828293	2034-10-02	U-2720		2020-12-02
N203567-001	10864274	2034-10-02	U-2720		2021-01-07
N203567-001	11654139	2034-10-02	U-1969		2023-06-14
N203567-001	9662394	2034-10-02		Drug product	2017-05-30
N203567-001	10478601	2035-04-25	U-2721	Drug product	2019-12-17

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	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AT	RLD, RS	2014-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`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	N203567-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203567-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203567-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203567-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203567-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203567-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203567-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203567-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203567-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203567-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203567-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203567-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203567-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203567-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203567-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203567-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203567-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N203567-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203567-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203567-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203567-001	AT	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203567-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203567-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203567-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203567-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203567-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203567-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203567-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203567-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203567-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203567-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203567-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203567-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203567-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203567-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 674 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203567-001	7214506	2026-02-22	U-281		2014-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10512640	2028-01-03	U-1969		2020-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10828369	2028-01-03		Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	11213519	2028-01-03	U-2720		2022-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	11872218	2028-01-03	U-1969		2024-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9566272	2028-01-03	U-1969		2017-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9877955	2028-01-03	U-1969		2018-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10105444	2030-07-08		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	8039494	2030-07-08	U-281		2014-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9861698	2030-07-08		Drug product	2018-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	8486978	2030-10-24		Drug product	2014-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9302009	2030-10-24		Drug product	2016-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10342875	2034-10-02	U-2720	Drug product	2019-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10828293	2034-10-02	U-2720		2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10864274	2034-10-02	U-2720		2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	11654139	2034-10-02	U-1969		2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9662394	2034-10-02		Drug product	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10478601	2035-04-25	U-2721	Drug product	2019-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203567-001	7214506	2026-02-22	U-281		2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10512640	2028-01-03	U-1969		2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10828369	2028-01-03		Drug product	2020-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	11213519	2028-01-03	U-2720		2022-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	11872218	2028-01-03	U-1969		2024-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9566272	2028-01-03	U-1969		2017-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9877955	2028-01-03	U-1969		2018-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10105444	2030-07-08		Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	8039494	2030-07-08	U-281		2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9861698	2030-07-08		Drug product	2018-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	8486978	2030-10-24		Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9302009	2030-10-24		Drug product	2016-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10342875	2034-10-02	U-2720	Drug product	2019-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10828293	2034-10-02	U-2720		2020-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10864274	2034-10-02	U-2720		2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	11654139	2034-10-02	U-1969		2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9662394	2034-10-02		Drug product	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10478601	2035-04-25	U-2721	Drug product	2019-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	7214506	2026-02-22	U-281		2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	10512640	2028-01-03	U-1969		2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	10828369	2028-01-03		Drug product	2020-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	11213519	2028-01-03	U-2720		2022-01-20	`31067a03dcf5…`

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	N203567-001	NPP	2023-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203567-001	NPP	2023-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203567-001	NPP	2023-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203567-001	NCE	2019-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203567-001	NPP	2023-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203567-001	NPP	2023-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203567-001	NPP	2023-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203567-001	NPP	2023-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203567-001	NPP	2023-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203567-001	NPP	2023-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203567-001	NCE	2019-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203567-001	NCE	2019-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203567-001	NCE	2019-06-06	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N203567-001	NPP	2023-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203567-001	NPP	2023-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203567-001	NPP	2023-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203567-001	NPP	2023-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203567-001	NPP	2023-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203567-001	NPP	2023-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203567-001	NPP	2023-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203567-001	NPP	2023-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203567-001	NPP	2023-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203567-001	NPP	2023-04-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203567-001	NPP	2023-04-27	`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
JUBLIA	EFINACONAZOLE	Bausch Health US LLC	922d4d25-c530-11e1-9b21-0800200c9a66	2025-07-01	Adverse reactions	Exact identifier application applno (NDA): 203567 application number: NDA203567 ndc (product): 0187-5400

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-5400	JUBLIA	efinaconazole	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current
0187-5400	JUBLIA	efinaconazole	Bausch Health US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70689	SUPPL	2022-04-05
70681	SUPPL	2022-04-04
62691	SUPPL	2020-04-27
62685	SUPPL	2020-04-27
45525	SUPPL	2016-10-12
45388	SUPPL	2016-09-27
19483	SUPPL	2015-03-20
32443	SUPPL	2015-03-02
24439	ORIG	2014-07-03
43439	ORIG	2014-07-02
32442	ORIG	2014-06-10
19482	ORIG	2014-06-10