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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084114
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB Yes Yes
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
02/05/2020 SUPPL-123 Labeling-Package Insert

Label is not available on this site.

02/23/2017 SUPPL-119 Labeling-Package Insert

Label is not available on this site.

08/29/2016 SUPPL-118 Labeling-Container/Carton Labels, Labeling-Package Insert

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.

04/26/1988 SUPPL-82 Labeling

Label is not available on this site.

07/05/1988 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.

12/08/1987 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

09/05/1986 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-68 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

04/26/1982 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

06/15/1982 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 212630 ENALTEC
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 212144 GLENMARK PHARMS LTD
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 212996 LANNETT CO INC
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 214827 MSN
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 214256 SUN PHARM
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 215659 TEVA PHARMS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription Yes AB 084114 UPSHER SMITH LABS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 213368 ZYDUS
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