Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021140
Company: J AND J CONSUMER INC
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 J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET;ORAL Over-the-counter No 209837 PERRIGO R AND D
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET;ORAL Over-the-counter No 077500 SUN PHARM INDS LTD

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