Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065146
Company: YUNG SHIN PHARM

Products on ANDA 065146

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFACLOR	CEFACLOR	EQ 250MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
CEFACLOR	CEFACLOR	EQ 500MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065146

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2024	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
09/12/2008	SUPPL-3	Labeling		Label is not available on this site.
09/26/2008	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065146

CEFACLOR

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFACLOR	CEFACLOR	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065146	YUNG SHIN PHARM

CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFACLOR	CEFACLOR	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065146	YUNG SHIN PHARM