Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050717
Company: ZAMBON SPA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONUROL FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION;ORAL Prescription AA 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
12/19/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050717Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/12/2018 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050717s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050717Orig1s010ltr.pdf
05/31/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050717s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050717Orig1s009ltr.pdf
04/11/2011 SUPPL-7 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/2011/050717s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050717s007ltr.pdf
03/11/2008 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050717s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050717s005ltr.pdf
12/18/2002 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50717SLR004_Monurol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50717slr004ltr.pdf
05/13/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1998 SUPPL-1 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
11/12/2018 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050717s010lbl.pdf
05/31/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050717s009lbl.pdf
04/11/2011 SUPPL-7 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/2011/050717s007lbl.pdf
03/11/2008 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050717s005lbl.pdf
12/18/2002 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50717SLR004_Monurol_lbl.pdf

MONUROL

FOR SOLUTION;ORAL; EQ 3GM BASE/PACKET
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSFOMYCIN TROMETHAMINE FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION;ORAL Prescription No AA 212548 XIROMED
MONUROL FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION;ORAL Prescription Yes AA 050717 ZAMBON SPA

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