Application 065058

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFACLOR	CEFACLOR	TABLET, EXTENDED RELEASE;ORAL	EQ 375MG BASE	No	No
002	CEFACLOR	CEFACLOR	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG BASE	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
A065058-001	CEFACLOR	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL			2002-09-04
A065058-002	CEFACLOR	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2002-09-04

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL		2002-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2002-09-04	`bb7c543d1eb4…`

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
Cefaclor	CEFACLOR	Teva Pharmaceuticals USA, Inc.	0878bdc2-0410-4938-9890-96523aa81c2f	2019-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065058 application number: ANDA065058 ndc (product): 0093-1087

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1087	Cefaclor	Cefaclor	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1087	Cefaclor	Cefaclor	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1087	Cefaclor	Cefaclor	Teva Pharmaceuticals USA, Inc.	ANDA	Current