Drugs@FDA: FDA-Approved Drugs
Company: WYETH PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LODINE | ETODOLAC | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
LODINE | ETODOLAC | 300MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
LODINE | ETODOLAC | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
LODINE | ETODOLAC | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/31/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
10/11/2007 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018922s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018922s023ltr.pdf | |
01/18/2006 | SUPPL-22 | 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 | |
05/24/2005 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018922s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018922s021ltr.pdf | |
05/24/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
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05/24/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
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05/24/2005 | SUPPL-18 | Labeling |
Label is not available on this site. |
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05/24/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/08/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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06/28/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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06/28/1996 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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06/28/1996 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
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12/08/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
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12/08/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/19/1993 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/29/1993 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
07/29/1993 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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01/12/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/12/1993 | SUPPL-5 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018922Orig1s005.pdf |
11/25/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/04/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/28/1992 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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02/11/1992 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/11/2007 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018922s023lbl.pdf | |
01/18/2006 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018922s022,020584s009lbl.pdf | |
05/24/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018922s021lbl.pdf |