Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018657
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLAGYL I.V. RTU 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 |
|---|---|---|---|---|---|---|---|
| 12/24/1981 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
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-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018657s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018657Orig1s039ltr.pdf | |
| 03/05/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018657s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018657Orig1s038ltr.pdf | |
| 12/04/2017 | SUPPL-36 | 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/2017/018657s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018657s036ltr.pdf |
| 01/13/2016 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/2015 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018657s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018657Orig1s034ltr.pdf | |
| 10/24/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018657Orig1s032ltr.pdf | |
| 08/05/2011 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018657s031ltr.pdf | |
| 08/06/2009 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018657s029ltr.pdf | |
| 05/25/2012 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018657s028ltr.pdf |
| 06/02/2004 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf | |
| 06/02/2004 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf | |
| 01/30/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1997 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1995 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/1994 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1992 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/02/1993 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1991 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/02/1991 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/28/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/24/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-7 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/13/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/08/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-1 | Labeling |
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-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018657s039lbl.pdf | |
| 03/05/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018657s038lbl.pdf | |
| 12/04/2017 | SUPPL-36 | 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/2017/018657s036lbl.pdf |
| 07/13/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018657s034lbl.pdf | |
| 10/24/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf | |
| 08/05/2011 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf | |
| 08/06/2009 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf | |
| 06/02/2004 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf | |
| 06/02/2004 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf |
FLAGYL I.V. RTU 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 |