Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217665
Company: AMNEAL

Products on ANDA 217665

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217665

METRONIDAZOLE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 500MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLAGYL I.V. RTU IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018657	BAXTER HLTHCARE
METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	217665	AMNEAL
METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212435	GLAND
METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018890	HOSPIRA
METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	206191	INFORLIFE