Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019645
Company: ROCHE PALO
Company: ROCHE PALO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TORADOL | KETOROLAC TROMETHAMINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/20/1991 | 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 |
---|---|---|---|---|---|
03/26/2013 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019645Orig1s019ltr.pdf | |
12/16/2008 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019645s018ltr.pdf |
11/13/2007 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s017ltr.pdf | |
01/19/2007 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s016ltr.pdf | |
10/11/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
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10/11/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
10/11/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/11/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
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10/11/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/07/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/11/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/18/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/26/2013 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf | |
11/13/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf | |
01/19/2007 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s016lbl.pdf |