Drugs@FDA: FDA-Approved Drugs
Company: KENVUE BRANDS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | 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 |
---|---|---|---|---|---|---|---|
11/30/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/11/2018 | SUPPL-26 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021140Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021140Orig1s026ltr.pdf | |
04/12/2017 | SUPPL-25 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021140Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021140Orig1s025ltr.pdf | |
12/02/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/01/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/03/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/03/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/2015 | SUPPL-20 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021140Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021140Orig1s020ltr.pdf | |
08/07/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/03/2012 | SUPPL-16 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021140s016ltr.pdf |
02/05/2008 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021140s013ltr.pdf |
09/14/2007 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021140s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021140s012ltr.pdf | |
04/30/2008 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020606se8-014, 021140se8-011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020606se8-014, 021140se8-011_SUMR.pdf |
06/16/2004 | SUPPL-3 | 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/2004/021140_S003_IMODIUM_ADVANCED_CAPLETS.pdf |
01/27/2003 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21140slr002_imodium_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21140slr002ltr.pdf | |
09/12/2001 | SUPPL-1 | 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 |
---|---|---|---|---|---|
12/11/2018 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021140Orig1s026lbl.pdf | |
04/12/2017 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021140Orig1s025lbl.pdf | |
03/18/2015 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021140Orig1s020lbl.pdf | |
09/14/2007 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021140s012lbl.pdf | |
01/27/2003 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21140slr002_imodium_lbl.pdf | |
11/30/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_prntlbl.pdf |
IMODIUM MULTI-SYMPTOM RELIEF
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;125MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | Yes | 021140 | KENVUE BRANDS |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 211059 | AUROBINDO PHARMA LTD |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 213484 | BIONPHARMA |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 214541 | GUARDIAN DRUG |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 211438 | HETERO LABS LTD V |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 209837 | PERRIGO R AND D |