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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075665
Company: TEVA

Products on ANDA 075665

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75665ltrTA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/14/2006	SUPPL-7	Labeling		Label is not available on this site.
03/02/2006	SUPPL-6	Labeling		Label is not available on this site.
04/19/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/2001	SUPPL-3	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf
02/05/2001	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf
02/05/2001	SUPPL-1	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75665S1,2,3ltr.pdf

Therapeutic Equivalents for ANDA 075665

ETODOLAC

TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212263	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076174	TARO
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075665	TEVA
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091134	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL	Prescription	No	AB	212263	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076174	TARO
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075665	TEVA
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091134	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL	Prescription	No	AB	212263	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076174	TARO
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075665	TEVA
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091134	ZYDUS PHARMS

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