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 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
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.

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	A065146-001	CEFACLOR	EQ 250MG BASE	CAPSULE / ORAL			2004-01-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065146-002	CEFACLOR	EQ 500MG BASE	CAPSULE / ORAL		RS	2004-01-22	`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 · 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