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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020606
Company: J AND J CONSUMER INC

Summary Review

Products on NDA 020606

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020606

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.

Labels for NDA 020606

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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