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LODINE XL | ETODOLAC | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
LODINE XL | ETODOLAC | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
LODINE XL | ETODOLAC | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |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