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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214745
Company: FRESENIUS KABI USA

Products on ANDA 214745

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214745

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214745

DIAZEPAM

INJECTABLE;INJECTION; 10MG/2ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	218450	ALEMBIC
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210363	BELOTECA
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214745	FRESENIUS KABI USA
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	070313	HIKMA
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	072079	HOSPIRA

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