Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080439
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
01/03/1973 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-224 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-222 Labeling-Package Insert

Label is not available on this site.

07/21/2009 SUPPL-221 Labeling

Label is not available on this site.

09/08/2008 SUPPL-220 Labeling

Label is not available on this site.

08/19/2008 SUPPL-217 Labeling

Label is not available on this site.

12/16/2002 SUPPL-211 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-210 Labeling

Label is not available on this site.

10/24/2001 SUPPL-209 Labeling

Label is not available on this site.

03/08/2002 SUPPL-208 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-207 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2001 SUPPL-206 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2001 SUPPL-205 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1999 SUPPL-204 Manufacturing (CMC)

Label is not available on this site.

05/05/1999 SUPPL-203 Manufacturing (CMC)

Label is not available on this site.

08/20/1998 SUPPL-202 Labeling

Label is not available on this site.

10/08/1998 SUPPL-201 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-200 Labeling

Label is not available on this site.

11/20/1998 SUPPL-199 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-198 Manufacturing (CMC)

Label is not available on this site.

02/02/1995 SUPPL-197 Manufacturing (CMC)

Label is not available on this site.

03/30/1990 SUPPL-195 Labeling

Label is not available on this site.

11/09/1989 SUPPL-194 Labeling

Label is not available on this site.

08/26/1988 SUPPL-193 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-192 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-191 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-190 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-189 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-187 Labeling

Label is not available on this site.

11/15/1988 SUPPL-186 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-185 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-184 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-183 Labeling

Label is not available on this site.

11/15/1988 SUPPL-182 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-181 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-180 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-179 Labeling

Label is not available on this site.

11/15/1988 SUPPL-177 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-176 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-175 Labeling

Label is not available on this site.

11/15/1988 SUPPL-174 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-173 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-172 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-171 Labeling

Label is not available on this site.

11/15/1988 SUPPL-170 Manufacturing (CMC)

Label is not available on this site.

11/15/1988 SUPPL-169 Manufacturing (CMC)

Label is not available on this site.

07/15/1987 SUPPL-168 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-167 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-165 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-164 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-162 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-161 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-159 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-158 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-156 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-155 Manufacturing (CMC)

Label is not available on this site.

02/25/1987 SUPPL-153 Manufacturing (CMC)

Label is not available on this site.

05/29/1986 SUPPL-152 Manufacturing (CMC)

Label is not available on this site.

01/02/1986 SUPPL-151 Manufacturing (CMC)

Label is not available on this site.

01/02/1986 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

01/02/1986 SUPPL-149 Manufacturing (CMC)

Label is not available on this site.

01/02/1986 SUPPL-148 Manufacturing (CMC)

Label is not available on this site.

02/08/1985 SUPPL-144 Manufacturing (CMC)

Label is not available on this site.

11/21/1984 SUPPL-143 Manufacturing (CMC)

Label is not available on this site.

11/21/1984 SUPPL-142 Manufacturing (CMC)

Label is not available on this site.

02/08/1985 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

02/08/1985 SUPPL-139 Manufacturing (CMC)

Label is not available on this site.

11/21/1984 SUPPL-138 Manufacturing (CMC)

Label is not available on this site.

12/16/1983 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

04/12/1983 SUPPL-132 Manufacturing (CMC)

Label is not available on this site.

04/12/1983 SUPPL-131 Manufacturing (CMC)

Label is not available on this site.

08/11/1982 SUPPL-130 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-129 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-128 Manufacturing (CMC)

Label is not available on this site.

06/18/1982 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

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