Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073122
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG 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
08/30/1991 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2016 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2000 SUPPL-18 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/16/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/27/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/27/1996 SUPPL-10 Labeling

Label is not available on this site.

12/27/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/18/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/16/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/16/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/27/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/02/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/20/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/20/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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