Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020429
Company: WYETH CONS
Company: WYETH CONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORUDIS KT | KETOPROFEN | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/06/1995 | 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 |
---|---|---|---|---|---|
09/10/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s008ltr.pdf |
08/30/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s007ltr.pdf |
02/20/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/23/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/14/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/26/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
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11/03/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |