Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
07/08/2024 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018900s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018900Orig1s043ltr.pdf | |
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. |
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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. |
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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 |
---|---|---|---|---|---|
07/08/2024 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018900s043lbl.pdf | |
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 |