Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 086863
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE;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
11/07/1980 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-29 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/03/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

04/30/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/15/1999 SUPPL-20 Labeling

Label is not available on this site.

09/02/1999 SUPPL-19 Labeling

Label is not available on this site.

09/25/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/28/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/09/1989 SUPPL-13 Labeling

Label is not available on this site.

08/13/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/26/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/14/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/14/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/31/1983 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