Viewing data from:

FOSFOMYCIN TROMETHAMINE

ANDA

FOSFOMYCIN TROMETHAMINE | A212548 | XIROMED PHARMA ESPANA SL

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

ERCROS SAFOSFOMYCIN TROMETHAMINE

DMF 311952017

QUIMICA SINTETICA SAFOSFOMYCIN TROMETHAMINE

DMF 332942018

HONOUR LAB LIMITEDFOSFOMYCIN TROMETHAMINE

DMF 403352024

MSN ORGANICS PRIVATE LTDFOSFOMYCIN TROMETHAMINE USP

DMF 404602024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 7, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 3GM BASE/PACKET

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Oct 6, 2020

No patent or exclusivity listings for this strength.