Application 065145

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARITHROMYCIN	CLARITHROMYCIN	TABLET, EXTENDED RELEASE;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065145-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2004-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065145-001	AB

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 2 · 41 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	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065145-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065145-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065145-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065145-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065145-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065145-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065145-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065145-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065145-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065145-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065145-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065145-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065145-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065145-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065145-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065145-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065145-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065145-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065145-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065145-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065145-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065145-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065145-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065145-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065145-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065145-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065145-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065145-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065145-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065145-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065145-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065145-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065145-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065145-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065145-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065145-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065145-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065145-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065145-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065145-001	AB	1	`cb3db0bc1861…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clarithromycin	CLARITHROMYCIN	Actavis Pharma, Inc.	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065145 application number: ANDA065145 ndc (product): 0591-2805

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2805	clarithromycin	clarithromycin	Actavis Pharma, Inc.	ANDA	Current
0591-2805	clarithromycin	clarithromycin	Actavis Pharma, Inc.	ANDA	Current
0591-2805	clarithromycin	clarithromycin	Actavis Pharma, Inc.	ANDA	Current
0591-2805	clarithromycin	clarithromycin	Actavis Pharma, Inc.	ANDA	Current
0591-2805	clarithromycin	clarithromycin	Actavis Pharma, Inc.	ANDA	Current
42291-263	clarithromycin	clarithromycin	AvKARE, Inc.	ANDA	Current
43063-520	clarithromycin	clarithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-520	clarithromycin	clarithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-520	clarithromycin	clarithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-565	clarithromycin	clarithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-565	clarithromycin	clarithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-565	clarithromycin	clarithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-565	clarithromycin	clarithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1410	clarithromycin	clarithromycin	A-S Medication Solutions	ANDA	Current
50090-1410	clarithromycin	clarithromycin	A-S Medication Solutions	ANDA	Current
55695-018	clarithromycin	clarithromycin	Department of State Health Services, Pharmacy Branch	ANDA	Current
66336-429	clarithromycin	clarithromycin	Dispensing Solutions, Inc.	ANDA	Current
67296-1072	clarithromycin	clarithromycin	RedPharm Drug, Inc.	ANDA	Current
67296-1072	clarithromycin	clarithromycin	RedPharm Drug, Inc.	ANDA	Current
67296-1072	clarithromycin	clarithromycin	RedPharm Drug, Inc.	ANDA	Current
68788-6887	clarithromycin	clarithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6887	clarithromycin	clarithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23735	ORIG	2006-03-03