Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018353
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLAGYL I.V. METRONIDAZOLE HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
FLAGYL I.V. RTU IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/28/1980 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2015 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018353s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018353Orig1s027ltr.pdf
08/16/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018353Orig1s026ltr.pdf
03/05/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-24 Labeling

Label is not available on this site.

04/13/1989 SUPPL-23 Labeling

Label is not available on this site.

02/17/1988 SUPPL-22 Labeling

Label is not available on this site.

09/09/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/02/1986 SUPPL-20 Labeling

Label is not available on this site.

04/24/1986 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/20/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-16 Labeling

Label is not available on this site.

02/17/1988 SUPPL-15 Efficacy-New Patient Population

Label is not available on this site.

02/17/1988 SUPPL-14 Labeling

Label is not available on this site.

10/29/1987 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/14/1983 SUPPL-10 Labeling

Label is not available on this site.

12/02/1982 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/15/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/30/1982 SUPPL-7 Labeling

Label is not available on this site.

01/11/1982 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1981 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/25/1981 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/20/1984 SUPPL-2 Labeling

Label is not available on this site.

05/29/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/13/2015 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018353s027lbl.pdf
08/16/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s026lbl.pdf

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