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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216422
Company: GALENICUM HLTH

Products on ANDA 216422

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216422

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216422

DIAZEPAM

INJECTABLE;INJECTION; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	216422	GALENICUM HLTH
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	070311	HIKMA
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	071583	HOSPIRA
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	211998	REGCON HOLDINGS

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