Drugs@FDA: FDA-Approved Drugs

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

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 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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