Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084113
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG 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-119 Labeling-Package Insert

Label is not available on this site.

08/29/2016 SUPPL-118 Labeling-Container/Carton Labels

Label is not available on this site.

09/13/2011 SUPPL-114 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-111 Labeling-Package Insert

Label is not available on this site.

08/24/2009 SUPPL-108 Labeling

Label is not available on this site.

11/19/2008 SUPPL-105 Labeling

Label is not available on this site.

11/25/2002 SUPPL-90 Labeling

Label is not available on this site.

03/22/1999 SUPPL-89 Labeling

Label is not available on this site.

03/22/1999 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

09/16/1992 SUPPL-86 Labeling

Label is not available on this site.

12/31/1991 SUPPL-85 Labeling

Label is not available on this site.

11/29/1990 SUPPL-84 Labeling

Label is not available on this site.

02/14/1989 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

04/26/1988 SUPPL-82 Labeling

Label is not available on this site.

07/08/1988 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

03/08/1988 SUPPL-80 Labeling

Label is not available on this site.

04/14/1988 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

12/07/1987 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

12/07/1987 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

03/12/1987 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

03/11/1986 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

02/01/1985 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

04/10/1984 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

04/26/1982 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 084113 UPSHER SMITH LABS

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