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Drugs@FDA: FDA-Approved Drugs

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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.html

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

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