Application 022554

Type: NDA
Sponsor: SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XIFAXAN	RIFAXIMIN	TABLET;ORAL	550MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog.

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	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022554-001	XIFAXAN	550MG	TABLET / ORAL	RLD, RS	2010-03-24	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 290 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022554-001	6861053	2019-08-11	U-1708		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	6861053	2019-08-11	U-1707		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7452857	2019-08-11	U-1708		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7452857	2019-08-11	U-1707		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7605240	2019-08-11	U-1707		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7605240	2019-08-11	U-1708		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7718608	2019-08-11	U-1707		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7718608	2019-08-11	U-1708		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7935799	2019-08-11	U-1707		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7935799	2019-08-11	U-1708		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7045620	2024-06-19		Drug substance		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7612199	2024-06-19		Drug substance, Drug product	2011-04-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7902206	2024-06-19		Drug substance, Drug product	2011-04-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8158644	2024-06-19		Drug product	2012-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8158781	2024-06-19		Drug substance	2012-05-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8835452	2024-06-19		Drug substance, Drug product	2014-10-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8853231	2024-06-19		Drug product	2014-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7915275	2025-02-23	U-1707		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7915275	2025-02-23	U-1708		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	7906542	2025-06-01		Drug substance, Drug product	2011-04-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8518949	2026-02-27		Drug product	2013-09-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8741904	2026-02-27	U-1526	Drug substance	2014-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8741904	2026-02-27	U-1707	Drug substance	2014-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8741904	2026-02-27	U-1708	Drug substance	2014-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	9271968	2026-02-27		Drug product	2016-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8193196	2027-09-02	U-1707	Drug substance, Drug product	2012-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8193196	2027-09-02	U-1708	Drug substance, Drug product	2012-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	10456384	2029-02-26	U-2643		2019-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	10456384	2029-02-26	U-2644		2019-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8309569	2029-07-18	U-1707		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8309569	2029-07-18	U-1708		2015-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8829017	2029-07-24	U-1562		2014-09-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8946252	2029-07-24	U-1481		2015-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	9629828	2029-07-24	U-1994		2017-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	10314828	2029-10-02	U-1481		2019-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	10335397	2029-10-02	U-2579		2019-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8642573	2029-10-02	U-1481			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	8969398	2029-10-02	U-1481		2015-03-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022554-001	9421195	2030-03-10	U-1481		2016-10-11	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022554-001	7045620	2024-06-19		Drug substance		`87673890dc5c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XIFAXAN	RIFAXIMIN	Cardinal Health 107, LLC	7afafa63-3236-4212-9589-045db6b01c0b	2025-08-27	Warnings, Adverse reactions	Name fallback brand name: XIFAXAN generic name: RIFAXIMIN
XIFAXAN	RIFAXIMIN	Salix Pharmaceuticals, Inc.	c5e8e2fd-7087-4b78-9181-cc259c0be2f1	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: XIFAXAN generic name: RIFAXIMIN
XIFAXAN	RIFAXIMIN	A-S Medication Solutions	f73acb74-e930-4414-81e9-d2a01db36e30	2023-02-04	Warnings, Adverse reactions	Name fallback brand name: XIFAXAN generic name: RIFAXIMIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72582	ORIG	2022-11-09
44510	ORIG	2015-11-05
44777	ORIG	2011-07-26
22053	ORIG	2011-07-26
7527	ORIG	2010-03-29
38836	ORIG	2010-03-26