Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020606
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, CHEWABLE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/26/1997 ORIG-1 Approval Type 4 - New Combination STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020606ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/12/2017 SUPPL-17 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020606Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020606Orig1s017ltr.pdf
04/30/2008 SUPPL-14 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-9 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/2004/020606_S009_IMODIUM_ADVANCED_CHEWABLE_TABLETS.pdf
06/21/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/03/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/04/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/14/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/04/1998 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1998 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
04/12/2017 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020606Orig1s017lbl.pdf

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