Application 065155

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARITHROMYCIN	CLARITHROMYCIN	TABLET;ORAL	250MG	No	No
002	CLARITHROMYCIN	CLARITHROMYCIN	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065155-001	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL			2005-05-31
A065155-002	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL			2005-05-31

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-05-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065155-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065155-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065155-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065155-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065155-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065155-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065155-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065155-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065155-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065155-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065155-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065155-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065155-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065155-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065155-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065155-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065155-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065155-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065155-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065155-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065155-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065155-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065155-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065155-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065155-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065155-002	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065155-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065155-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065155-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065155-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065155-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065155-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065155-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065155-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065155-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065155-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065155-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065155-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065155-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A065155-002	AB	1	`e64feba35796…`

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Sportpharm LLC	d836ae7e-fdbf-4dcb-a90d-ede1dcbc3e67	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	REMEDYREPACK INC.	9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Sportpharm LLC	de33ba3a-9df1-4076-8d5f-b603d2698096	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d42821d-ce7a-7d64-e063-6294a90a0875	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	88c7ded8-333c-408d-b693-a72881710f59	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Preferred Pharmaceuticals Inc.	81c0c69e-b1ae-42f3-9e85-09b8daa75d8d	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Major Pharmaceuticals	d0a66646-6774-4fc6-9b26-a98c3a5df274	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	American Health Packaging	59ebe6cb-c830-45c7-8242-52f9f42a90a0	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d4303f8-88dd-8b88-e063-6394a90ab48f	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	American Health Packaging	fa69ea92-0b41-43fb-918f-ed80e0dedf04	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	fad1e5a3-59f9-4868-9937-d3b061ab8f00	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	AvPAK	1920f943-bbf1-cfd9-7475-96a35680a9e0	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	471f638a-9dd1-09d3-e063-6294a90a2d4f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	f98aacb4-2f01-3e94-e053-6294a90a9aa0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
CLARITHROMYCIN	CLARITHROMYCIN	Chartwell RX, LLC	dea5bd78-7f93-4bc4-a2e4-1b021f5fe098	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: CLARITHROMYCIN generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	9eb306e0-ccfb-418c-82ca-204f20a788f7	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1d328f5d-73c1-4df7-a3df-71d0e0221181	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1cb8a78a-0f07-49e8-a23e-a77628006209	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	0be243c6-de02-45dd-8210-cab1bbc8dfa7	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Direct_Rx	3ba1da51-ba5b-323f-e063-6294a90a0333	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7528	Clarithromycin	Clarithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7528	Clarithromycin	Clarithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7528	Clarithromycin	Clarithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7529	Clarithromycin	Clarithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23736	ORIG	2006-03-03