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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089903
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
08/29/1989 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
02/19/2025 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
03/21/2017 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/26/2016 SUPPL-20 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
12/03/2010 SUPPL-18 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089903s018lbl.pdf
06/29/2009 SUPPL-17 Labeling

Label is not available on this site.
11/25/2008 SUPPL-16 Labeling

Label is not available on this site.
07/14/2004 SUPPL-10 Labeling

Label is not available on this site.
11/13/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
05/16/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
10/07/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
08/12/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
08/01/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
11/18/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
09/01/1993 SUPPL-3 Labeling

Label is not available on this site.
09/28/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
09/15/1989 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/03/2010 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089903s018lbl.pdf

PROCHLORPERAZINE EDISYLATE

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204147 AVET LIFESCIENCES
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 214379 CAPLIN
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 213873 EUGIA PHARMA
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 214107 GLAND
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 089903 HIKMA
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 210710 MYLAN LABS LTD
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 040540 SAGENT
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 212257 SOMERSET THERAPS LLC
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 213626 VIWIT PHARM
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