Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088133
Company: FOSUN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 25MG 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
08/30/1983 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
02/23/2017 SUPPL-47 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/19/2016 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

12/16/2002 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2002 SUPPL-41 Labeling

Label is not available on this site.

02/21/2001 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-39 Labeling

Label is not available on this site.

05/05/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/18/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/20/1998 SUPPL-35 Labeling

Label is not available on this site.

10/20/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/21/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/09/1990 SUPPL-32 Labeling

Label is not available on this site.

09/28/1989 SUPPL-31 Labeling

Label is not available on this site.

11/10/1988 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/18/1987 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/18/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/03/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/13/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/13/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/13/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/18/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/23/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/23/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/23/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/23/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/23/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/28/1984 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