Application 022436

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XERESE	ACYCLOVIR; HYDROCORTISONE	CREAM;TOPICAL	5%;1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022436-001	XERESE	ACYCLOVIR; HYDROCORTISONE	5%;1%	CREAM / TOPICAL		RLD, RS	2009-07-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022436-001	XERESE	5%;1%	CREAM / TOPICAL	RLD, RS	2009-07-31	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022436-001	7223387	2022-11-13	U-1006	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022436-001	7223387	2022-11-13	U-1484	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022436-001	7223387	2022-11-13	U-1006	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022436-001	7223387	2022-11-13	U-1484	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022436-001	7223387	2022-11-13	U-1006	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022436-001	7223387	2022-11-13	U-1484	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022436-001	7223387	2022-11-13	U-1006	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022436-001	7223387	2022-11-13	U-1484	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022436-001	7223387	2022-11-13	U-1484	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022436-001	7223387	2022-11-13	U-1006	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022436-001	7223387	2022-11-13	U-1006	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022436-001	7223387	2022-11-13	U-1484	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022436-001	7223387	2022-11-13	U-1006	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022436-001	7223387	2022-11-13	U-1484	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022436-001	7223387	2022-11-13	U-1006	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022436-001	7223387	2022-11-13	U-1484	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022436-001	7223387	2022-11-13	U-1006	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022436-001	7223387	2022-11-13	U-1484	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022436-001	7223387	2022-11-13	U-1006	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022436-001	7223387	2022-11-13	U-1484	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022436-001	7223387	2022-11-13	U-1006	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022436-001	7223387	2022-11-13	U-1484	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022436-001	7223387	2022-11-13	U-1006	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022436-001	7223387	2022-11-13	U-1484	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022436-001	7223387	2022-11-13	U-1006	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022436-001	7223387	2022-11-13	U-1484	Drug product	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	N022436-001	7223387	2022-11-13	U-1006	Drug product	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022436-001	7223387	2022-11-13	U-1484	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022436-001	7223387	2022-11-13	U-1484	Drug product	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022436-001	7223387	2022-11-13	U-1006	Drug product	`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
Xerese	ACYCLOVIR AND HYDROCORTISONE	Bausch Health US LLC	3b6ac164-0f1e-4f36-94a1-1fdb07d710f5	2020-08-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022436 application number: NDA022436 ndc (product): 0187-5104

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
0187-5104	Xerese	Acyclovir and Hydrocortisone	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5104	Xerese	Acyclovir and Hydrocortisone	Bausch Health US, LLC	NDA	Current
0187-5104	Xerese	Acyclovir and Hydrocortisone	Bausch Health US LLC	NDA	Current
0187-5104	Xerese	Acyclovir and Hydrocortisone	Bausch Health US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61251	SUPPL	2019-12-12
61243	SUPPL	2019-12-12
17590	SUPPL	2014-01-23
7401	SUPPL	2014-01-23
17589	SUPPL	2010-05-17
7400	SUPPL	2010-05-17
24309	ORIG	2010-01-13
22021	ORIG	2010-01-13
7399	ORIG	2009-08-17
67192	ORIG	1900-01-01
52984	SUPPL	1900-01-01
52982	SUPPL	1900-01-01
51429	SUPPL	1900-01-01