Drugs@FDA: FDA Approved Drug Products

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

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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