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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018922
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LODINE ETODOLAC 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No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LODINE ETODOLAC 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
LODINE ETODOLAC 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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.
05/24/2005 SUPPL-19 Labeling

Label is not available on this site.
05/24/2005 SUPPL-18 Labeling

Label is not available on this site.
05/24/2005 SUPPL-17 Labeling

Label is not available on this site.
12/08/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
06/28/1996 SUPPL-15 Labeling

Label is not available on this site.
06/28/1996 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.
06/28/1996 SUPPL-13 Efficacy-New Indication

Label is not available on this site.
12/08/1994 SUPPL-12 Labeling

Label is not available on this site.
12/08/1994 SUPPL-10 Labeling

Label is not available on this site.
03/19/1993 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
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.
01/12/1993 SUPPL-6 Labeling

Label is not available on this site.
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.
10/04/1991 SUPPL-3 Labeling

Label is not available on this site.
10/28/1992 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.
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
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