Application 065146

Type: ANDA
Sponsor: YUNG SHIN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFACLOR	CEFACLOR	CAPSULE;ORAL	EQ 250MG BASE	No	No
002	CEFACLOR	CEFACLOR	CAPSULE;ORAL	EQ 500MG BASE	No	No

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
A065146-001	CEFACLOR	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22
A065146-002	CEFACLOR	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22

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	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL	AB		2004-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL	AB		2004-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL	AB		2004-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL	AB		2004-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL	AB		2004-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL	AB		2004-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL	AB		2004-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL	AB		2004-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL	AB		2004-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL	AB		2004-01-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A065146-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065146-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065146-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065146-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065146-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065146-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065146-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065146-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065146-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065146-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065146-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065146-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065146-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065146-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065146-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065146-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065146-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065146-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065146-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065146-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065146-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065146-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065146-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065146-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A065146-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065146-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065146-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065146-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065146-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065146-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065146-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065146-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065146-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065146-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065146-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065146-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065146-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065146-002	AB	1	`3bdfa0b2c4d7…`

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
Cefaclor	CEFACLOR	Carlsbad Technology, Inc.	2f61354e-bcb0-41aa-955f-51eabc11387b	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065146 application number: ANDA065146 ndc (product): 61442-172 ndc (product): 61442-171
Cefaclor	CEFACLOR	A-S Medication Solutions	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065146 application number: ANDA065146 ndc (product): 50090-1602

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1602	Cefaclor	Cefaclor	A-S Medication Solutions	ANDA	Current
61442-171	Cefaclor	Cefaclor	Carlsbad Technology, Inc.	ANDA	Current
61442-172	Cefaclor	Cefaclor	Carlsbad Technology, Inc.	ANDA	Current
63629-1007	Cefaclor	Cefaclor	Bryant Ranch Prepack	ANDA	Current
63629-1007	Cefaclor	Cefaclor	Bryant Ranch Prepack	ANDA	Current