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 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
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.

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
2026-08-01 22:54:32	2026-06	A065058-001	CEFACLOR	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL			2002-09-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065058-002	CEFACLOR	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2002-09-04	`a50c72e98297…`

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 · 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