Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075074
Company: TARO PHARM INDS

Products on ANDA 075074

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075074

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75074ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/14/2009	SUPPL-13	Labeling		Label is not available on this site.
11/17/2006	SUPPL-12	Labeling		Label is not available on this site.
03/02/2006	SUPPL-10	Labeling		Label is not available on this site.
05/10/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
09/11/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
09/11/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
07/18/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/25/2000	SUPPL-2	Labeling		Label is not available on this site.
04/25/2000	SUPPL-1	Manufacturing (CMC)-New Strength		Label is not available on this site.

Therapeutic Equivalents for ANDA 075074

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	204729	IPCA LABS LTD
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	204729	IPCA LABS LTD
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	No	AB	074903	SANDOZ
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Prescription	No	AB	075074	TARO PHARM INDS