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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020448
Company: J AND J CONSUMER INC

Products on NDA 020448

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMODIUM A-D EZ CHEWS	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET, CHEWABLE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020448

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020448_imodium-ad_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2017	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020448Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020448Orig1s011ltr.pdf
05/22/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/20/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/27/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/11/2007	SUPPL-4	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020448s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020448s004ltr.pdf
09/10/1998	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/1998	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020448

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2017	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020448Orig1s011lbl.pdf
01/11/2007	SUPPL-4	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020448s004lbl.pdf

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