Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089556
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/16/1987 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-19 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/21/2009 SUPPL-14 Labeling

Label is not available on this site.

11/18/2008 SUPPL-12 Labeling

Label is not available on this site.

12/05/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

10/15/2001 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/01/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/20/1995 SUPPL-4 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