Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040185
Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET;ORAL Prescription AB No No
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE 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
10/28/1996 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-13 Labeling-Package Insert

Label is not available on this site.
12/03/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
07/22/2009 SUPPL-11 Labeling

Label is not available on this site.
11/19/2008 SUPPL-9 Labeling

Label is not available on this site.
05/29/2008 SUPPL-8 Labeling

Label is not available on this site.
06/22/2006 SUPPL-5 Labeling

Label is not available on this site.
12/13/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
12/09/2002 SUPPL-2 Labeling

Label is not available on this site.
02/05/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROCHLORPERAZINE MALEATE

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

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

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