Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019645
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TORADOL KETOROLAC TROMETHAMINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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.

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.

10/11/2001 SUPPL-6 Labeling

Label is not available on this site.

10/11/2001 SUPPL-5 Labeling

Label is not available on this site.

12/07/1994 SUPPL-4 Labeling

Label is not available on this site.

10/11/2001 SUPPL-3 Labeling

Label is not available on this site.

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

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