Application 050775

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIAXIN XL	CLARITHROMYCIN	TABLET, EXTENDED RELEASE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N050775-001	BIAXIN XL	CLARITHROMYCIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2000-03-03

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UTC	2026-02	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050775-001	BIAXIN XL	500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050775-001	BIAXIN XL	500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Sportpharm LLC	d836ae7e-fdbf-4dcb-a90d-ede1dcbc3e67	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	REMEDYREPACK INC.	9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Sportpharm LLC	de33ba3a-9df1-4076-8d5f-b603d2698096	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d42821d-ce7a-7d64-e063-6294a90a0875	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	88c7ded8-333c-408d-b693-a72881710f59	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Preferred Pharmaceuticals Inc.	81c0c69e-b1ae-42f3-9e85-09b8daa75d8d	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Major Pharmaceuticals	d0a66646-6774-4fc6-9b26-a98c3a5df274	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	American Health Packaging	59ebe6cb-c830-45c7-8242-52f9f42a90a0	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d4303f8-88dd-8b88-e063-6394a90ab48f	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	American Health Packaging	fa69ea92-0b41-43fb-918f-ed80e0dedf04	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	fad1e5a3-59f9-4868-9937-d3b061ab8f00	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	AvPAK	1920f943-bbf1-cfd9-7475-96a35680a9e0	2026-02-11	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	471f638a-9dd1-09d3-e063-6294a90a2d4f	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	f98aacb4-2f01-3e94-e053-6294a90a9aa0	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
CLARITHROMYCIN	CLARITHROMYCIN	Chartwell RX, LLC	dea5bd78-7f93-4bc4-a2e4-1b021f5fe098	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	9eb306e0-ccfb-418c-82ca-204f20a788f7	2025-11-01	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1d328f5d-73c1-4df7-a3df-71d0e0221181	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1cb8a78a-0f07-49e8-a23e-a77628006209	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	0be243c6-de02-45dd-8210-cab1bbc8dfa7	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Direct_Rx	3ba1da51-ba5b-323f-e063-6294a90a0333	2025-09-08	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60049	SUPPL	2019-09-19
60039	SUPPL	2019-09-19
56942	SUPPL	2018-12-31
56894	SUPPL	2018-12-20
56766	SUPPL	2018-12-18
56611	SUPPL	2018-11-30
48705	SUPPL	2017-06-12
48693	SUPPL	2017-06-12
18222	SUPPL	2016-06-01
30510	SUPPL	2016-05-31
18225	SUPPL	2015-10-29
30512	SUPPL	2015-10-28
18224	SUPPL	2015-01-12
30511	SUPPL	2015-01-09
18223	SUPPL	2014-08-07
8258	SUPPL	2014-07-28
18221	SUPPL	2013-09-24
8257	SUPPL	2013-09-11
8256	SUPPL	2013-09-11
18220	SUPPL	2013-09-09
30508	SUPPL	2012-07-10
18218	SUPPL	2012-07-10
8255	SUPPL	2012-06-05
30509	SUPPL	2012-05-09
8253	SUPPL	2012-05-09
39308	SUPPL	2012-05-07
18219	SUPPL	2012-05-07
39309	SUPPL	2011-05-31
18217	SUPPL	2011-05-31
8254	SUPPL	2011-05-31
8252	SUPPL	2011-05-31
8251	SUPPL	2009-11-20
18216	SUPPL	2009-09-22
30507	SUPPL	2008-05-29
8250	SUPPL	2008-01-09
39307	SUPPL	2007-12-27
30506	SUPPL	2006-07-13
44207	ORIG	2006-03-03
30505	SUPPL	2005-10-20
39306	SUPPL	2005-10-10
8249	SUPPL	2004-07-21
22232	SUPPL	2004-06-29
8248	SUPPL	2003-04-18
22231	SUPPL	2001-11-23
42731	ORIG	2001-10-11
39305	SUPPL	2001-08-03
8247	SUPPL	2001-08-03
39304	ORIG	2000-03-03
8246	ORIG	2000-03-03