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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091526
Company: FRESENIUS KABI USA

Products on ANDA 091526

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2013	ORIG-1	Approval	Not Applicable		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091526lbl.pdf

Labels for ANDA 091526

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091526lbl.pdf

Therapeutic Equivalents for ANDA 091526

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

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

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