Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075009
Company: TEVA

Products on ANDA 075009

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETODOLAC	ETODOLAC	400MG	TABLET;ORAL	Discontinued	None	No	No
ETODOLAC	ETODOLAC	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075009

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/1997	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
04/28/2021	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/26/2010	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/22/2006	SUPPL-12	Labeling		Label is not available on this site.
03/02/2006	SUPPL-11	Labeling		Label is not available on this site.
02/24/2000	SUPPL-9	Labeling		Label is not available on this site.
12/02/1999	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
12/02/1999	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
12/28/1999	SUPPL-6	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf
12/28/1999	SUPPL-5	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf
12/28/1999	SUPPL-4	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf
12/28/1999	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf
12/28/1999	SUPPL-2	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75009s002s003s004s005s006ltr.pdf
04/30/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.