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COLISTIMETHATE SODIUM

ANDA

COLISTIMETHATE SODIUM | A205356 | XELLIA PHARMACEUTICALS APS

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs

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

XELLIA PHARMACEUTICALS APSCOLISTIMETHATE SODIUM USP

DMF 133631998

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDCOLISTIMETHATE SODIUM

DMF 283502014

HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO LTDCOLISTIMETHATE SODIUM

DMF 351772020

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 2, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 150MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 29, 2015

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Colistimethate Sodium (XELLIA PHARMS APS, NDA 205356) received Restricted Distribution designation.

Old: No

New: Yes