Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019698
Company: ROCHE PALO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TORADOL KETOROLAC TROMETHAMINE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
TORADOL KETOROLAC TROMETHAMINE 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
11/30/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/17/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1998 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/25/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/04/1995 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1994 SUPPL-11 Labeling

Label is not available on this site.

04/24/1992 SUPPL-7 Labeling

Label is not available on this site.

04/24/1992 SUPPL-6 Labeling

Label is not available on this site.

12/17/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/07/1994 SUPPL-4 Efficacy-New Route Of Administration

Label is not available on this site.

11/18/1991 SUPPL-3 Labeling

Label is not available on this site.

04/15/1991 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1990 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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