Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040101
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET;ORAL Prescription AB No No
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET;ORAL Prescription AB No Yes
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 25MG BASE 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
07/19/1996 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-18 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

07/21/2009 SUPPL-15 Labeling

Label is not available on this site.

09/08/2008 SUPPL-14 Labeling

Label is not available on this site.

09/03/2008 SUPPL-13 Labeling

Label is not available on this site.

06/22/2006 SUPPL-10 Labeling

Label is not available on this site.

12/31/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

04/03/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

04/03/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/03/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROCHLORPERAZINE MALEATE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET;ORAL Prescription No AB 040185 MYLAN
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET;ORAL Prescription No AB 040101 SANDOZ
PROCOMP PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET;ORAL Prescription No AB 040268 JUBILANT CADISTA

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET;ORAL Prescription No AB 040185 MYLAN
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET;ORAL Prescription No AB 040101 SANDOZ
PROCOMP PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET;ORAL Prescription No AB 040268 JUBILANT CADISTA

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