Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018084
Company: ORTHO MCNEIL JANSSEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLECTIN DS TOLMETIN SODIUM EQ 400MG BASE CAPSULE;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
10/30/1979 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
01/22/2008 SUPPL-52 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/2008/018084s052ltr.pdf
02/09/2006 SUPPL-51 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
12/19/2000 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/25/2000 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/18/1993 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

01/21/1993 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1991 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/25/1991 SUPPL-41 Labeling

Label is not available on this site.

07/11/1991 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1989 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/17/1989 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1989 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1989 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1987 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1986 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1986 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/11/1985 SUPPL-28 Labeling

Label is not available on this site.

12/11/1985 SUPPL-27 Labeling

Label is not available on this site.

12/11/1985 SUPPL-26 Labeling

Label is not available on this site.

02/07/1985 SUPPL-25 Labeling

Label is not available on this site.

10/05/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1985 SUPPL-21 Labeling

Label is not available on this site.

04/06/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/25/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/31/1983 SUPPL-18 Labeling

Label is not available on this site.

01/31/1983 SUPPL-17 Labeling

Label is not available on this site.

04/29/1988 SUPPL-12 Efficacy-New Dosing Regimen

Label is not available on this site.

01/15/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/16/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/18/1985 SUPPL-7 Labeling

Label is not available on this site.

07/27/1982 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/01/1981 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1981 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-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018084s052,017628s068lbl.pdf
02/09/2006 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017628s067,018084s051lbl.pdf

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