An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062713
Company: BELCHER PHARMS

Products on ANDA 062713

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/1988	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
05/04/2011	SUPPL-5	Labeling		Label is not available on this site.
03/22/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/27/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062713

CEPHALEXIN

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	090836	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065248	ANDA REPOSITORY
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065253	AUROBINDO PHARMA
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	062713	BELCHER PHARMS
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065152	CHARTWELL RX
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065229	LUPIN
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	062702	TEVA

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	090836	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065248	ANDA REPOSITORY
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065253	AUROBINDO PHARMA
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	062713	BELCHER PHARMS
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065152	CHARTWELL RX
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065229	LUPIN
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	062702	TEVA

Top