Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080365
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION 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
02/13/1974 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-166 Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-165 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-163 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-162 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/04/1996 SUPPL-161 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/27/1998 SUPPL-160 Manufacturing (CMC)

Label is not available on this site.

08/16/1995 SUPPL-159 Manufacturing (CMC)

Label is not available on this site.

05/11/1992 SUPPL-158 Labeling

Label is not available on this site.

05/27/1992 SUPPL-157 Manufacturing (CMC)

Label is not available on this site.

04/10/1991 SUPPL-156 Labeling

Label is not available on this site.

01/11/1990 SUPPL-155 Labeling

Label is not available on this site.

10/16/1989 SUPPL-153 Manufacturing (CMC)

Label is not available on this site.

07/02/1991 SUPPL-152 Manufacturing (CMC)

Label is not available on this site.

07/02/1991 SUPPL-151 Manufacturing (CMC)

Label is not available on this site.

07/02/1991 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

10/16/1989 SUPPL-149 Manufacturing (CMC)

Label is not available on this site.

10/16/1989 SUPPL-148 Manufacturing (CMC)

Label is not available on this site.

04/18/1989 SUPPL-147 Manufacturing (CMC)

Label is not available on this site.

04/18/1989 SUPPL-146 Manufacturing (CMC)

Label is not available on this site.

04/18/1989 SUPPL-145 Manufacturing (CMC)

Label is not available on this site.

04/10/1989 SUPPL-139 Bioequivalence

Label is not available on this site.

04/20/1989 SUPPL-138 Bioequivalence

Label is not available on this site.

06/16/1986 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

06/30/1988 SUPPL-41 Labeling

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