Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017694
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IMODIUM LOPERAMIDE HYDROCHLORIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
12/28/1976 ORIG-1 Approval Type 1 - New Molecular Entity 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-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017694s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017690Orig1s005,017694Orig1s052ltr.pdf
10/21/2005 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017694s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017694s050ltr.pdf
10/13/1999 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1999 SUPPL-47 Labeling

Label is not available on this site.

06/30/1998 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/02/1998 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/01/1993 SUPPL-41 Labeling

Label is not available on this site.

08/24/1993 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/17/1999 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1992 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1988 SUPPL-37 Labeling

Label is not available on this site.

05/26/1988 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1987 SUPPL-35 Labeling

Label is not available on this site.

09/16/1986 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1985 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-32 Labeling

Label is not available on this site.

08/02/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1984 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/1983 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/15/1983 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1983 SUPPL-27 Labeling

Label is not available on this site.

12/15/1982 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1982 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1982 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/1983 SUPPL-22 Labeling

Label is not available on this site.

05/19/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/31/1984 SUPPL-19 Labeling

Label is not available on this site.

05/14/1981 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1981 SUPPL-17 Labeling

Label is not available on this site.

06/13/1980 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/26/1980 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/05/1979 SUPPL-14 Labeling

Label is not available on this site.

10/03/1979 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1979 SUPPL-12 Labeling

Label is not available on this site.

06/25/1979 SUPPL-11 Labeling

Label is not available on this site.

04/05/1979 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/05/1979 SUPPL-9 Labeling

Label is not available on this site.

03/14/1979 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/30/1978 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/30/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1978 SUPPL-5 Labeling

Label is not available on this site.

04/24/1978 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1978 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-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017694s052lbl.pdf
10/21/2005 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017694s050lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English