Application 065283

Type: ANDA
Sponsor: SANDOZ

Application Products#

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

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
A065283-002	CLARITHROMYCIN	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04
A065283-003	CLARITHROMYCIN	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-09-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-09-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

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	A065283-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065283-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065283-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065283-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065283-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065283-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065283-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065283-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065283-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065283-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065283-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065283-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065283-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065283-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065283-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065283-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065283-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065283-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065283-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065283-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065283-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065283-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065283-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065283-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065283-003	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A065283-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065283-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065283-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065283-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065283-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065283-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065283-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065283-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065283-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A065283-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065283-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065283-003	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	fad1e5a3-59f9-4868-9937-d3b061ab8f00	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065283 application number: ANDA065283 ndc (product): 50090-0994
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	22457862-0f88-4be8-b507-1c8f264269f2	2023-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065283 application number: ANDA065283 ndc (product): 0781-6023 ndc (product): 0781-6022

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-6022	Clarithromycin	Clarithromycin	Sandoz Inc	ANDA	Current
0781-6022	Clarithromycin	Clarithromycin	Sandoz Inc	ANDA	Current
0781-6022	Clarithromycin	Clarithromycin	Sandoz Inc	ANDA	Current
0781-6023	Clarithromycin	Clarithromycin	Sandoz Inc	ANDA	Current
0781-6023	Clarithromycin	Clarithromycin	Sandoz Inc	ANDA	Current
0781-6023	Clarithromycin	Clarithromycin	Sandoz Inc	ANDA	Current
50090-0994	Clarithromycin	Clarithromycin	A-S Medication Solutions	ANDA	Current
50090-0994	Clarithromycin	Clarithromycin	A-S Medication Solutions	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23744	ORIG	2007-09-24