Drugs@FDA: FDA-Approved Drugs

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

• Safety Labeling Change Order Letter

Products on ANDA 089903

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089903

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
03/21/2017	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/26/2016	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert		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.

Labels for ANDA 089903

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

Therapeutic Equivalents for ANDA 089903

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	214192	AMNEAL
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 PHARMA LTD
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	213630	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	204860	NEXUS
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	213626	VIWIT PHARM