Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017690
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMODIUM LOPERAMIDE HYDROCHLORIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No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
12/28/1976 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017690s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017690Orig1s005,017694Orig1s052ltr.pdf
08/24/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/02/1992 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/03/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017690s005lbl.pdf

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