Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074256
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;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
10/31/1993 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
09/18/2017 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

10/03/2016 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

04/29/2015 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

04/29/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

01/12/2010 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

03/26/2009 SUPPL-28 Labeling

Label is not available on this site.

01/06/2005 SUPPL-24 Labeling

Label is not available on this site.

04/11/2002 SUPPL-19 Labeling

Label is not available on this site.

12/02/1999 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

01/10/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/12/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/08/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/28/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/18/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/28/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

GEMFIBROZIL

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 075034 APOTEX
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 202726 AUROBINDO PHARMA LTD
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 203266 CADILA PHARMS LTD
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 078012 CARIBE HOLDINGS
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 074270 CHARTWELL MOLECULES
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 078599 HIKMA PHARMS
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 078207 IMPAX PHARMS
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 077836 INVAGEN PHARMS
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 079072 NORTHSTAR HLTHCARE
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 079239 SUN PHARM INDS INC
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 074256 TEVA
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 204189 ZYDUS PHARMS
LOPID GEMFIBROZIL 600MG TABLET;ORAL Prescription Yes AB 018422 PFIZER PHARMS

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