Drugs@FDA: FDA-Approved Drugs
Company: J AND J CONSUMER INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMODIUM | LOPERAMIDE HYDROCHLORIDE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/28/1976 | 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 |
|---|---|---|---|---|---|
| 11/03/2016 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017694s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017690Orig1s005,017694Orig1s052ltr.pdf | |
| 10/21/2005 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017694s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017694s050ltr.pdf | |
| 10/13/1999 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1999 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 06/30/1998 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1998 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/01/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1993 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1999 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/1992 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1988 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/26/1988 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1987 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 09/16/1986 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/02/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1984 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1983 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1983 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/15/1982 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1982 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/03/1982 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/27/1983 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1984 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/14/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/13/1980 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1980 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/03/1979 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/25/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/05/1979 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/05/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/14/1979 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/30/1978 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/30/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/03/2016 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017694s052lbl.pdf | |
| 10/21/2005 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017694s050lbl.pdf |