Application 050662

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIAXIN	CLARITHROMYCIN	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	BIAXIN	CLARITHROMYCIN	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050662-001	BIAXIN	CLARITHROMYCIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-10-31
N050662-002	BIAXIN	CLARITHROMYCIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-10-31

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 2 of 3 · 88 observed 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UTC	2019-12	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`3a93d1ddd44b…`

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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	ba216276-b0bd-420a-9e0d-090bdfcc2460	2025-08-05	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60047	SUPPL	2019-09-19
60037	SUPPL	2019-09-19
56940	SUPPL	2018-12-31
56892	SUPPL	2018-12-20
56765	SUPPL	2018-12-18
56561	SUPPL	2018-11-26
48703	SUPPL	2017-06-12
48691	SUPPL	2017-06-12
39079	SUPPL	2016-06-01
7952	SUPPL	2016-05-31
17992	SUPPL	2015-10-29
30245	SUPPL	2015-10-28
17991	SUPPL	2015-01-12
7954	SUPPL	2015-01-09
39080	SUPPL	2014-08-07
7953	SUPPL	2014-07-28
30244	SUPPL	2013-09-11
7951	SUPPL	2013-09-11
17990	SUPPL	2013-09-09
17989	SUPPL	2013-09-09
30243	SUPPL	2012-07-10
17988	SUPPL	2012-07-10
7949	SUPPL	2012-06-05
7950	SUPPL	2012-05-09
7947	SUPPL	2012-05-09
39078	SUPPL	2012-05-07
17986	SUPPL	2012-05-07
39077	SUPPL	2011-05-31
30242	SUPPL	2011-05-31
17987	SUPPL	2011-05-31
7948	SUPPL	2011-05-31
30241	SUPPL	2009-11-20
17985	SUPPL	2009-09-22
30240	SUPPL	2008-05-29
30239	SUPPL	2008-01-09
17984	SUPPL	2007-12-27
30238	SUPPL	2006-07-13
44201	ORIG	2006-03-03
30237	SUPPL	2005-10-20
39076	SUPPL	2005-10-10
30236	SUPPL	2004-07-21
42666	SUPPL	2004-06-29
22174	SUPPL	2004-06-29
22173	SUPPL	2004-06-29
30235	SUPPL	2002-06-06
7946	SUPPL	2002-06-06
42667	SUPPL	2001-11-23
30234	SUPPL	2000-10-20
17983	SUPPL	2000-10-20
42665	SUPPL	1999-08-02