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001	BIAXIN	CLARITHROMYCIN	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	BIAXIN	CLARITHROMYCIN	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

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N050662-001	BIAXIN	CLARITHROMYCIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-10-31
N050662-002	BIAXIN	CLARITHROMYCIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-10-31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 1 of 3 · 86 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	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050662-002	BIAXIN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050662-001	BIAXIN	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050662-001	BIAXIN	250MG	TABLET / ORAL	RLD	1991-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050662-002	BIAXIN	500MG	TABLET / ORAL	RLD	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050662-001	BIAXIN	250MG	TABLET / ORAL	RLD	1991-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050662-002	BIAXIN	500MG	TABLET / ORAL	RLD	1991-10-31	`4b0b4de00fa7…`
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…`

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
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