An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021140
Company: KENVUE BRANDS

Summary Review

Products on NDA 021140

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021140

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.

Labels for NDA 021140

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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

Top