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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212435
Company: GLAND PHARMA LTD

Products on ANDA 212435

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 212435

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212435Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/17/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/17/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212435

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
METRO I.V. IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018900	B BRAUN
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	078084	BAXTER HLTHCARE CORP
METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212435	GLAND PHARMA LTD
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

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