Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018657
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
12/04/2017 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
12/04/2017 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 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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