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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075126
Company: ANI PHARMS

Products on ANDA 075126

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	AB	No	No
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075126

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75126ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/07/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/11/2007	SUPPL-3	Labeling		Label is not available on this site.
03/02/2006	SUPPL-2	Labeling		Label is not available on this site.
05/08/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075126

ETODOLAC

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	No	AB	075126	ANI PHARMS
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	No	AB	075419	APOTEX
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	No	AB	075078	TARO

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	No	AB	075126	ANI PHARMS
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	No	AB	075419	APOTEX
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	No	AB	075078	TARO

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