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 A-D | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/22/1989 | 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 |
|---|---|---|---|---|---|
| 03/07/2019 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019860Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019860Orig1s033ltr.pdf | |
| 04/12/2017 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Label (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032ltr.pdf | |
| 02/21/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/2012 | SUPPL-29 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019860s029ltr.pdf |
| 06/16/2004 | SUPPL-20 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019860_S020_IMODIUM_CHEWABLE_TABLETS.pdf |
| 09/26/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2001 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19860S18ltr.pdf |
| 05/11/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/06/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1995 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/06/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1991 | 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 |
|---|---|---|---|---|---|
| 03/07/2019 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019860Orig1s033lbl.pdf | |
| 04/12/2017 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032lbl.pdf | |
| 04/12/2017 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019860Orig1s032ltr.pdf |
IMODIUM A-D
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 2MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | Yes | 019860 | J AND J CONSUMER INC |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 206548 | AUROBINDO PHARMA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 075232 | L PERRIGO CO |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 076497 | LNK |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 074091 | OHM LABS |