Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017690
Company: J AND J CONSUMER INC

Products on NDA 017690

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IMODIUM	LOPERAMIDE HYDROCHLORIDE	2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017690

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.

Labels for NDA 017690

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