Application 211882

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARAZLO	TAZAROTENE	LOTION;TOPICAL	0.045%	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
N211882-001	ARAZLO	TAZAROTENE	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211882-001	11679116	2036-06-06		Drug product	2023-07-13
N211882-001	11311482	2038-05-11	U-2368		2022-05-05
N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08

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.

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	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N211882-001	AB	1	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 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	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`5c6f7cd8ea54…`
2020-12-22 03:56 UTC	2020-12	N211882-001	6517847	2020-08-03	U-2368	Drug product	2020-01-08	`8869cabd3fbd…`

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	N211882-001	NP	2022-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211882-001	NP	2022-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211882-001	NP	2022-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211882-001	NP	2022-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211882-001	NP	2022-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211882-001	NP	2022-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211882-001	NP	2022-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211882-001	NP	2022-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211882-001	NP	2022-12-18	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N211882-001	NP	2022-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211882-001	NP	2022-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211882-001	NP	2022-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211882-001	NP	2022-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211882-001	NP	2022-12-18	`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
Arazlo	TAZAROTENE	Bausch Health US, LLC	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211882 application number: NDA211882 ndc (product): 0187-2098

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-2098	Arazlo	tazarotene	Bausch Health US, LLC	NDA	Current
0187-2098	Arazlo	tazarotene	Bausch Health US LLC	NDA	Current
0187-2098	Arazlo	tazarotene	Bausch Health US, LLC	NDA	Current
0187-2098	Arazlo	tazarotene	Bausch Health US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63844	ORIG	2020-07-10
61365	ORIG	2019-12-20
61350	ORIG	2019-12-19
63246	ORIG	1900-01-01