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 42.

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 · 84 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
2026-08-18 06:07:40	2026-07	A065283-002	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION / ORAL			2007-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065283-003	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION / ORAL		RS	2007-09-04	`caaa826d4ba7…`
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…`

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#

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 · 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