Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075034
Company: APOTEX
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
07/20/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75034_Gemfibrozil.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/2019 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2017 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

10/03/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

05/08/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

05/08/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

03/14/2011 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

11/22/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/21/2006 SUPPL-15 Labeling

Label is not available on this site.

08/01/2005 SUPPL-12 Labeling

Label is not available on this site.

11/04/2005 SUPPL-11 Labeling

Label is not available on this site.

03/25/2002 SUPPL-3 Labeling

Label is not available on this site.

01/31/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/26/2001 SUPPL-1 Labeling

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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