Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062702
Company: TEVA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/1987 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
08/21/2012 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

02/22/2011 SUPPL-58 Labeling-Package Insert

Label is not available on this site.

11/16/2009 SUPPL-56 Labeling

Label is not available on this site.

09/27/2007 SUPPL-54 Labeling

Label is not available on this site.

02/08/2007 SUPPL-52 Labeling

Label is not available on this site.

11/13/2003 SUPPL-49 Labeling

Label is not available on this site.

09/22/2003 SUPPL-48 Labeling

Label is not available on this site.

07/31/2002 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/2002 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

12/20/1999 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/02/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/07/1997 SUPPL-35 Labeling

Label is not available on this site.

01/10/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/03/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/03/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/14/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/13/1993 SUPPL-28 Labeling

Label is not available on this site.

10/13/1993 SUPPL-27 Labeling

Label is not available on this site.

10/13/1992 SUPPL-26 Labeling

Label is not available on this site.

10/13/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/10/1992 SUPPL-24 Labeling

Label is not available on this site.

03/20/1989 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/27/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/27/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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 065253 AUROBINDO PHARMA LTD
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062713 BELCHER PHARMS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065215 HIKMA
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065229 LUPIN
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065248 ORCHID HLTHCARE
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062702 TEVA
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065152 YUNG SHIN PHARM
KEFLEX CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA

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 065253 AUROBINDO PHARMA LTD
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 062713 BELCHER PHARMS
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065215 HIKMA
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065229 LUPIN
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065248 ORCHID HLTHCARE
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 062702 TEVA
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065152 YUNG SHIN PHARM
KEFLEX CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA

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