Drugs@FDA: FDA-Approved Drugs
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| MOTRIN | IBUPROFEN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MOTRIN | IBUPROFEN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MOTRIN | IBUPROFEN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MOTRIN | IBUPROFEN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |