Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062703
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No Yes
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-54 Labeling-Package Insert

Label is not available on this site.

02/22/2011 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

11/16/2009 SUPPL-51 Labeling

Label is not available on this site.

09/27/2007 SUPPL-49 Labeling

Label is not available on this site.

02/09/2007 SUPPL-47 Labeling

Label is not available on this site.

01/13/2004 SUPPL-40 Labeling

Label is not available on this site.

01/13/2004 SUPPL-39 Labeling

Label is not available on this site.

08/01/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

01/18/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/19/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/10/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/27/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/17/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/13/1993 SUPPL-21 Labeling

Label is not available on this site.

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

Label is not available on this site.

09/14/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/30/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/04/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/25/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/31/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

CEPHALEXIN

FOR SUSPENSION;ORAL; EQ 125MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 210221 ALKEM LABS LTD
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065234 LUPIN
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065326 ORCHID HLTHCARE
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 062703 TEVA
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065336 YUNG SHIN PHARM

FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 210221 ALKEM LABS LTD
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065234 LUPIN
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065326 ORCHID HLTHCARE
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 062703 TEVA
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065336 YUNG SHIN PHARM

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