Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017628
Company: ORTHO MCNEIL JANSSEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLECTIN TOLMETIN SODIUM EQ 200MG BASE TABLET;ORAL Discontinued None No No
TOLECTIN 600 TOLMETIN SODIUM EQ 600MG BASE TABLET;ORAL Discontinued None No 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
03/24/1976 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
01/22/2008 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017628s068ltr.pdf
02/09/2006 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018084s051,017628s067ltr.pdf
03/21/2001 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

02/26/2001 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

01/21/1993 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1992 SUPPL-58 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/25/1991 SUPPL-57 Labeling

Label is not available on this site.

07/11/1991 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1992 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1989 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

08/17/1990 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1989 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1989 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1989 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1987 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1986 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1986 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1989 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/11/1985 SUPPL-40 Labeling

Label is not available on this site.

12/11/1985 SUPPL-39 Labeling

Label is not available on this site.

12/11/1985 SUPPL-38 Labeling

Label is not available on this site.

10/19/1988 SUPPL-37 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/07/1985 SUPPL-36 Labeling

Label is not available on this site.

10/05/1984 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1984 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1985 SUPPL-33 Labeling

Label is not available on this site.

03/08/1989 SUPPL-31 Efficacy-New Dosing Regimen

Label is not available on this site.

05/25/1983 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/31/1983 SUPPL-29 Labeling

Label is not available on this site.

01/31/1983 SUPPL-28 Labeling

Label is not available on this site.

01/18/1985 SUPPL-27 Labeling

Label is not available on this site.

04/29/1988 SUPPL-24 Efficacy-New Dosing Regimen

Label is not available on this site.

12/11/1984 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/18/1985 SUPPL-19 Labeling

Label is not available on this site.

06/16/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/27/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/30/1981 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/19/1980 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/22/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/18/1985 SUPPL-12 Labeling

Label is not available on this site.

11/22/1981 SUPPL-11 Labeling

Label is not available on this site.

03/13/1979 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1979 SUPPL-8 Efficacy

Label is not available on this site.

02/21/1978 SUPPL-5 Efficacy

Label is not available on this site.

05/15/1979 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/23/1976 SUPPL-3 Labeling

Label is not available on this site.

06/28/1976 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/23/1976 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
01/22/2008 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf
02/09/2006 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf

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