Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078012
Company: CARIBE HOLDINGS
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
03/26/2007 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
12/13/2018 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/18/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

05/14/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/14/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/30/2012 SUPPL-6 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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