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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078084
Company: BAXTER HLTHCARE CORP

Products on ANDA 078084

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 078084

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/08/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/28/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/08/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/13/2009	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/15/2009	SUPPL-3	Labeling		Label is not available on this site.
04/07/2011	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078084

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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