Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020584
Company: WYETH PHARMS INC
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LODINE XL ETODOLAC 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
LODINE XL ETODOLAC 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
LODINE XL ETODOLAC 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
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
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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