Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083329
Company: WEST-WARD PHARMS INT

Products on ANDA 083329

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083329

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/1974	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
02/05/2020	SUPPL-47	Labeling-Package Insert		Label is not available on this site.
02/04/2020	SUPPL-46	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-43	Labeling-Package Insert		Label is not available on this site.
06/29/2009	SUPPL-42	Labeling		Label is not available on this site.
11/25/2008	SUPPL-41	Labeling		Label is not available on this site.
11/25/2002	SUPPL-35	Labeling		Label is not available on this site.
09/18/2000	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.
10/06/1999	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
10/06/1999	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/1999	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
09/07/1999	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
04/14/1999	SUPPL-29	Labeling		Label is not available on this site.
03/19/1998	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
12/09/1993	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/28/1991	SUPPL-26	Labeling		Label is not available on this site.
02/27/1992	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
11/08/1989	SUPPL-24	Labeling		Label is not available on this site.
02/15/1989	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/15/1989	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 083329

CHLORPROMAZINE HYDROCHLORIDE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211816	EUGIA PHARMA
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	083329	WEST-WARD PHARMS INT
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217275	ZYDUS PHARMS