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 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
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 · 86 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
2026-09-14 22:38:34	2026-08	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065155-001	CLARITHROMYCIN	250MG	TABLET / ORAL		2005-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065155-002	CLARITHROMYCIN	500MG	TABLET / ORAL		2005-05-31	`caaa826d4ba7…`
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…`

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Asclemed USA, Inc.	a12e4d38-e0f8-4467-a26c-bb25a342aa92	2020-10-20	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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