Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018890
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
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
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
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 205531 MYLAN LABS LTD

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