Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040120
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET;ORAL Discontinued None No No
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE 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
07/11/1996 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
02/23/2017 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

07/22/2009 SUPPL-11 Labeling

Label is not available on this site.

11/19/2008 SUPPL-10 Labeling

Label is not available on this site.

05/15/2008 SUPPL-9 Labeling

Label is not available on this site.

06/22/2006 SUPPL-8 Labeling

Label is not available on this site.

06/25/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/1999 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