Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078207
Company: IMPAX PHARMS

Products on ANDA 078207

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078207

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2007	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
09/12/2022	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/28/2009	SUPPL-3	Labeling		Label is not available on this site.
05/26/2010	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078207

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	214603	ASCENT PHARMS INC
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	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
LOPID	GEMFIBROZIL	600MG	TABLET;ORAL	Prescription	Yes	AB	018422	PFIZER PHARMS