Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083386
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB 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
07/09/1974 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-95 Labeling-Package Insert

Label is not available on this site.

08/29/2016 SUPPL-94 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/13/2011 SUPPL-90 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-87 Labeling-Package Insert

Label is not available on this site.

08/18/2009 SUPPL-84 Labeling

Label is not available on this site.

11/19/2008 SUPPL-81 Labeling

Label is not available on this site.

11/25/2002 SUPPL-66 Labeling

Label is not available on this site.

03/22/1999 SUPPL-65 Labeling

Label is not available on this site.

03/22/1999 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

09/16/1992 SUPPL-62 Labeling

Label is not available on this site.

12/31/1991 SUPPL-61 Labeling

Label is not available on this site.

11/29/1990 SUPPL-60 Labeling

Label is not available on this site.

04/14/1989 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

10/24/1988 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

04/26/1988 SUPPL-57 Labeling

Label is not available on this site.

03/08/1988 SUPPL-55 Labeling

Label is not available on this site.

04/14/1988 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

03/10/1986 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/26/1984 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

11/26/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/26/1984 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 083386 UPSHER SMITH LABS

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