Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212548
Company: XIROMED

Products on ANDA 212548

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSFOMYCIN TROMETHAMINE	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212548Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212548

FOSFOMYCIN TROMETHAMINE

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