Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018890
Company: HOSPIRA
Company: HOSPIRA
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 11/18/1983 | 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 |
|---|---|---|---|---|---|
| 03/14/2025 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018890s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018890Orig1s058ltr.pdf | |
| 07/08/2024 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018890s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018890Orig1s057ltr.pdf | |
| 10/06/2023 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018890s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018890Orig1s055ltr.pdf | |
| 12/15/2021 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018890s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018890Orig1s054ltr.pdf | |
| 03/05/2021 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018890s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018890Orig1s053ltr.pdf | |
| 04/03/2018 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018890s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018890Orig1s052ltr.pdf | |
| 01/22/2016 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/2015 | SUPPL-50 | 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/2015/018890s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018890Orig1s050ltr.pdf |
| 08/01/2014 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/2008 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 01/26/2004 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/06/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1997 | SUPPL-27 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/12/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1996 | SUPPL-25 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/03/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/23/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/24/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/19/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/28/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1984 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 03/14/2025 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018890s058lbl.pdf | |
| 07/08/2024 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018890s057lbl.pdf | |
| 10/06/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018890s055lbl.pdf | |
| 12/15/2021 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018890s054lbl.pdf | |
| 03/05/2021 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018890s053lbl.pdf | |
| 04/03/2018 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018890s052lbl.pdf | |
| 07/13/2015 | SUPPL-50 | 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/2015/018890s050lbl.pdf |
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 |
| 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 | 212435 | GLAND |
| 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 |