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 1 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
2026-09-14 22:38:34	2026-08	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050698-002	BIAXIN	250MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050698-003	BIAXIN	187MG/5ML	FOR SUSPENSION / ORAL		1998-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050698-001	BIAXIN	125MG/5ML	FOR SUSPENSION / ORAL	RLD	1993-12-23	`301d65b070ca…`

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
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