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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076004
Company: APOTEX INC

Products on ANDA 076004

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETODOLAC	ETODOLAC	400MG	TABLET;ORAL	Prescription	AB	No	No
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076004

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2002	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
04/29/2021	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/07/2013	SUPPL-8	Labeling		Label is not available on this site.
04/04/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076004

ETODOLAC

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	400MG	TABLET;ORAL	Prescription	No	AB	208834	AMNEAL PHARMS CO
ETODOLAC	ETODOLAC	400MG	TABLET;ORAL	Prescription	No	AB	076004	APOTEX INC
ETODOLAC	ETODOLAC	400MG	TABLET;ORAL	Prescription	No	AB	210704	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	400MG	TABLET;ORAL	Prescription	No	AB	074903	SANDOZ
ETODOLAC	ETODOLAC	400MG	TABLET;ORAL	Prescription	No	AB	075074	TARO PHARM INDS

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	No	AB	208834	AMNEAL PHARMS CO
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	No	AB	076004	APOTEX INC
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	No	AB	210704	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	No	AB	074903	SANDOZ
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	No	AB	075074	TARO PHARM INDS

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