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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018900
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRO I.V. IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/29/1983 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
12/15/2021 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018900Orig1s041ltr.pdf
03/05/2021 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018900Orig1s039ltr.pdf
04/29/2021 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018900Orig1s038ltr.pdf
04/11/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018900s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018900Orig1s035ltr.pdf
07/13/2015 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018900Orig1s032ltr.pdf
12/08/2015 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018900Orig1s031ltr.pdf
03/25/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
06/23/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
08/20/2008 SUPPL-27 Labeling

Label is not available on this site.
07/21/2007 SUPPL-25 Labeling

Label is not available on this site.
02/20/2004 SUPPL-23 Labeling

Label is not available on this site.
07/08/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
05/12/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
03/22/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
03/17/1993 SUPPL-14 Labeling

Label is not available on this site.
11/06/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
09/30/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
06/12/1991 SUPPL-11 Labeling

Label is not available on this site.
01/25/1989 SUPPL-10 Labeling

Label is not available on this site.
09/01/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
06/17/1988 SUPPL-7 Labeling

Label is not available on this site.
03/11/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2021 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s041lbl.pdf
04/29/2021 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s038lbl.pdf
03/05/2021 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018900s039lbl.pdf
04/11/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018900s035lbl.pdf
12/08/2015 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s031lbl.pdf
07/13/2015 SUPPL-32 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018900s032lbl.pdf

METRO I.V. 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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