Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080817
Company: WEST-WARD PHARMS INT

Products on ANDA 080817

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080817

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/1972	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
11/05/2002	SUPPL-41	Labeling		Label is not available on this site.
10/01/1999	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1998	SUPPL-39	Labeling		Label is not available on this site.
02/11/1999	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
01/29/1998	SUPPL-36	Labeling		Label is not available on this site.
06/08/1999	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
02/17/1993	SUPPL-34	Labeling		Label is not available on this site.
10/30/1992	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
11/05/1990	SUPPL-32	Labeling		Label is not available on this site.
07/23/1992	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
01/27/1992	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
06/07/1990	SUPPL-29	Labeling		Label is not available on this site.
11/23/1988	SUPPL-28	Labeling		Label is not available on this site.
11/03/1986	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
04/10/1986	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
02/08/1983	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080817

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040466	APP PHARMS
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	218448	GLAND PHARMA LTD
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205723	MICRO LABS
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040498	MYLAN INSTITUTIONAL
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	080817	WEST-WARD PHARMS INT
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091526	FRESENIUS KABI USA