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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020584
Company: WYETH PHARMS INC

Products on NDA 020584

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LODINE XL	ETODOLAC	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
LODINE XL	ETODOLAC	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
LODINE XL	ETODOLAC	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020584

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2006	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018922s022_020584s009ltr.pdf
05/25/2005	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf
05/25/2005	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf
08/11/2000	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_LodineXL.cfm
05/25/2005	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020584s004,006,007ltr.pdf
05/27/1999	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine.cfm
01/23/1998	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/03/1998	SUPPL-1	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-584S001.pdf

Labels for NDA 020584

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2006	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.pdf
05/25/2005	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf
05/25/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf
05/25/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf
08/11/2000	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_prntlbl.pdf
05/27/1999	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-584S003_Lodine_prntlbl.pdf

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