Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040466
Company: APP PHARMS

Products on ANDA 040466

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040466

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40466ltr.pdf

Therapeutic Equivalents for ANDA 040466

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