Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088461
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 15MG 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
11/18/1983 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-22 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/01/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/23/1990 SUPPL-14 Labeling

Label is not available on this site.

08/19/1988 SUPPL-12 Labeling

Label is not available on this site.

06/02/1988 SUPPL-11 Labeling

Label is not available on this site.

03/03/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/31/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/22/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/05/1984 SUPPL-2 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