Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019487
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION;ORAL | Discontinued | None | Yes | No |
| IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 03/01/1988 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 08/07/2019 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019487Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019487Orig1s034ltr.pdf | |
| 04/12/2017 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019487Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019487Orig1s032ltr.pdf | |
| 04/12/2017 | SUPPL-30 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/17/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2016 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019487Orig1s028ltr.pdf | |
| 03/18/2015 | SUPPL-27 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019487Orig1s027ltr.pdf | |
| 06/08/2005 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019487s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019487_s023_IMODIUM A-D LIQUID.pdf |
| 07/08/2004 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487scf022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019487_S022_IMODIUM_A-D LIQUID.pdf |
| 06/16/2004 | SUPPL-21 | 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/2004/019487_S021_IMODIUM A-D LIQUID.pdf |
| 12/03/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/28/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/22/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/12/1996 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/15/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/16/1992 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/17/1991 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1993 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/23/1992 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1988 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/07/2019 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019487Orig1s034lbl.pdf | |
| 04/12/2017 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019487Orig1s032lbl.pdf | |
| 04/05/2016 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf | |
| 03/18/2015 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.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.
SOLUTION;ORAL; 1MG/7.5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION;ORAL | Over-the-counter | Yes | 019487 | KENVUE BRANDS |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION;ORAL | Over-the-counter | No | 220100 | BIONPHARMA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SOLUTION;ORAL | Over-the-counter | No | 091292 | PERRIGO R AND D |