An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050717
Company: ZAMBON SPA

Products on NDA 050717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONUROL	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050717

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	Letter (PDF)	Label is not available on this site.	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.

Labels for NDA 050717

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

Top