Application 050698

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIAXIN	CLARITHROMYCIN	FOR SUSPENSION;ORAL	125MG/5ML	Yes	No
002	BIAXIN	CLARITHROMYCIN	FOR SUSPENSION;ORAL	250MG/5ML	Yes	No
003	BIAXIN	CLARITHROMYCIN	FOR SUSPENSION;ORAL	187MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050698-001	BIAXIN	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23
N050698-002	BIAXIN	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23
N050698-003	BIAXIN	CLARITHROMYCIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`3f01610625f2…`

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
60048	SUPPL	2019-09-19
60038	SUPPL	2019-09-19
56941	SUPPL	2018-12-31
56893	SUPPL	2018-12-20
56767	SUPPL	2018-12-18
56612	SUPPL	2018-11-30
48704	SUPPL	2017-06-12
48692	SUPPL	2017-06-12
18040	SUPPL	2016-06-01
30299	SUPPL	2016-05-31
18041	SUPPL	2015-10-29
30301	SUPPL	2015-10-28
39134	SUPPL	2015-01-12
8033	SUPPL	2015-01-09
39133	SUPPL	2014-08-07
30300	SUPPL	2014-07-28
30298	SUPPL	2013-09-11
8032	SUPPL	2013-09-11
18039	SUPPL	2013-09-09
18038	SUPPL	2013-09-09
18037	SUPPL	2012-07-10
8030	SUPPL	2012-07-10
30297	SUPPL	2012-06-05
30296	SUPPL	2012-05-09
8031	SUPPL	2012-05-09
39132	SUPPL	2012-05-07
18036	SUPPL	2012-05-07
39131	SUPPL	2011-05-31
39130	SUPPL	2011-05-31
30295	SUPPL	2011-05-31
8029	SUPPL	2011-05-31
8028	SUPPL	2009-11-20
39129	SUPPL	2009-09-22
8027	SUPPL	2008-05-29
30294	SUPPL	2008-01-09
18035	SUPPL	2007-12-27
44204	ORIG	2006-09-25
8026	SUPPL	2006-07-13
8025	SUPPL	2005-10-20
18034	SUPPL	2005-10-10
8024	SUPPL	2004-07-21
8023	SUPPL	2002-05-24