Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206191
Company: INFORLIFE
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
02/25/2019 ORIG-1 Approval STANDARD

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 Yes AP 018890 HOSPIRA
METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE;INJECTION Prescription No AP 206191 INFORLIFE
METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE;INJECTION Prescription No AP 205531 MYLAN LABS LTD

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