Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040268
Company: JUBILANT CADISTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCOMP PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET;ORAL Prescription AB No No
PROCOMP PROCHLORPERAZINE MALEATE EQ 10MG 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
02/27/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40268ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/18/2009 SUPPL-15 Labeling

Label is not available on this site.

07/15/2009 SUPPL-14 Labeling

Label is not available on this site.

04/30/2009 SUPPL-13 Labeling

Label is not available on this site.

01/14/2010 SUPPL-12 Labeling

Label is not available on this site.

12/18/2008 SUPPL-11 Labeling

Label is not available on this site.

09/03/2008 SUPPL-9 Labeling

Label is not available on this site.

06/07/2006 SUPPL-5 Labeling

Label is not available on this site.

04/20/2004 SUPPL-3 Labeling

Label is not available on this site.

11/16/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROCOMP

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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