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CLARITHROMYCIN	TABLET, EXTENDED RELEASE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

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N050775-001	BIAXIN XL	CLARITHROMYCIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2000-03-03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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`caaa826d4ba7…`
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UTC	2026-02	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`011fe1cb6892…`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of this ZIP	2025-12	N050775-001	BIAXIN XL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2000-03-03	`31067a03dcf5…`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…`

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	25debd85-0840-4f8d-9898-027772061dd2	2025-06-09	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
clarithromycin	CLARITHROMYCIN	Actavis Pharma, Inc.	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Coupler LLC	2d6cfd87-9b8c-bba9-e063-6294a90aff5a	2025-02-05	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	NuCare Pharmaceuticals,Inc.	9143b79c-4c79-43ac-e053-2995a90ad708	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	DirectRx	d22bd12c-737b-4aab-e053-2995a90aff60	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	27e02b77-4332-49e0-8d0c-a072cf5dff92	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	28f60574-4ecd-441c-aebe-5b1d18033ef6	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	0c7d8391-50ef-4827-abe6-e0fc0c2f1636	2024-01-16	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Rising Pharma Holdings, Inc.	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	2024-01-05	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	adba78c2-9e51-4bed-8c6a-6f977f79c40c	2023-12-14	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Lannett Company, Inc.	9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7	2023-11-13	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Aurobindo Pharma Limited	9aaffb41-408c-4372-8fd5-1d649450c0e9	2023-10-10	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Lannett Company, Inc.	71a836d0-d60f-6418-e053-2a95a90aa6ef	2023-09-22	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	22457862-0f88-4be8-b507-1c8f264269f2	2023-09-13	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23	2023-07-31	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	2023-05-30	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Alembic Pharmaceuticals Limited	268d21f9-02c9-41b0-9487-7968ea12720d	2023-05-29	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Alembic Pharmaceuticals Inc.	cde51c9f-f7b8-413f-8b8e-e56370cd5754	2023-05-26	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
CLARITHROMYCIN	CLARITHROMYCIN	Chartwell RX, LLC.	99d2fd6b-39ca-42f9-ad06-30e7fbc22c47	2022-12-23	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	b1bdf526-4f16-4130-b614-4cb678f060d7	2021-01-01	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
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