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Drugs@FDA: FDA-Approved Drugs

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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	FOR SOLUTION;ORAL	Prescription	AA	Yes	Yes

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	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.

Labels for NDA 050717

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

Therapeutic Equivalents for NDA 050717

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	214554	ALKEM LABS LTD
FOSFOMYCIN TROMETHAMINE	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION;ORAL	Prescription	No	AA	216600	AMNEAL
FOSFOMYCIN TROMETHAMINE	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION;ORAL	Prescription	No	AA	211881	CIPLA
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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