Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017463
Company: MCNEIL CONSUMER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOTRIN IBUPROFEN 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MOTRIN IBUPROFEN 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MOTRIN IBUPROFEN 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MOTRIN IBUPROFEN 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
09/19/1974 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
09/10/2007 SUPPL-105 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017463s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017463s105ltr.pdf
01/24/2006 SUPPL-104 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017463s104ltr.pdf
05/14/2001 SUPPL-103 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2001 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

11/29/1999 SUPPL-101 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1999 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

11/20/1995 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1995 SUPPL-97 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1995 SUPPL-95 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1992 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

12/26/1990 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1989 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

06/22/1994 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1990 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1988 SUPPL-79 Labeling

Label is not available on this site.

02/16/1988 SUPPL-78 Labeling

Label is not available on this site.

02/16/1988 SUPPL-77 Labeling

Label is not available on this site.

11/27/1987 SUPPL-75 Labeling

Label is not available on this site.

12/16/1986 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

10/10/1986 SUPPL-72 Labeling

Label is not available on this site.

10/10/1986 SUPPL-71 Labeling

Label is not available on this site.

10/10/1986 SUPPL-70 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1985 SUPPL-69 Labeling

Label is not available on this site.

10/31/1990 SUPPL-68 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/22/1986 SUPPL-65 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/22/1985 SUPPL-63 Labeling

Label is not available on this site.

05/29/1984 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1983 SUPPL-57 Labeling

Label is not available on this site.

05/22/1985 SUPPL-53 Labeling

Label is not available on this site.

03/01/1982 SUPPL-52 Labeling

Label is not available on this site.

07/02/1981 SUPPL-51 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/02/1981 SUPPL-50 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/01/1982 SUPPL-49 Labeling

Label is not available on this site.

03/31/1981 SUPPL-48 Labeling

Label is not available on this site.

09/12/1980 SUPPL-47 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/01/1982 SUPPL-46 Labeling

Label is not available on this site.

12/21/1979 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1980 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1979 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/16/1979 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

08/21/1979 SUPPL-40 Efficacy

Label is not available on this site.

03/22/1979 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/27/1979 SUPPL-38 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/12/1978 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1979 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1978 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/23/1978 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1978 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/03/1978 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/07/1977 SUPPL-28

Label is not available on this site.

08/21/1979 SUPPL-24 Labeling

Label is not available on this site.

12/14/1976 SUPPL-22 Labeling

Label is not available on this site.

09/08/1976 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/27/1976 SUPPL-18 Labeling

Label is not available on this site.

05/03/1976 SUPPL-17 Efficacy

Label is not available on this site.

03/01/1976 SUPPL-16 Labeling

Label is not available on this site.

11/12/1975 SUPPL-13 Labeling

Label is not available on this site.

11/12/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1975 SUPPL-11 Labeling

Label is not available on this site.

05/03/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/10/2007 SUPPL-105 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017463s105lbl.pdf
01/24/2006 SUPPL-104 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf

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