Application 064166

Type: ANDA
Sponsor: RANBAXY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFACLOR	CEFACLOR	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064166-001	CEFACLOR	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL			1997-10-02

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A064166-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	1997-10-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064166-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	1997-10-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A064166-001	CEFACLOR	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	1997-10-02	`a50c72e98297…`

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 · 4 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	Name fallback brand name: Cefaclor generic name: CEFACLOR
Cefaclor	CEFACLOR	A-S Medication Solutions	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Cefaclor generic name: CEFACLOR
Cefaclor	CEFACLOR	Azorian Pharma, LLC	224af904-38f3-4210-a750-e21006db4c66	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Cefaclor generic name: CEFACLOR
Cefaclor	CEFACLOR	Teva Pharmaceuticals USA, Inc.	0878bdc2-0410-4938-9890-96523aa81c2f	2019-07-31	Warnings, Adverse reactions	Name fallback brand name: Cefaclor generic name: CEFACLOR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42790	ORIG	2003-07-31