Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040153
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Discontinued None No No
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Discontinued None No No
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE TABLET;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
10/25/1996 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
09/03/2008 SUPPL-3 Labeling

Label is not available on this site.

09/04/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

09/04/2002 SUPPL-1 Manufacturing (CMC)-Packaging

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