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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075419
Company: APOTEX

Products on ANDA 075419

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 075419

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75419ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2021	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/07/2013	SUPPL-8	Labeling		Label is not available on this site.
04/25/2006	SUPPL-5	Labeling		Label is not available on this site.
11/15/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 075419

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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