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COLY-MYCIN M

NDA

COLISTIMETHATE SODIUM | N050108 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

6 letters from Drugs@FDA

Date	Submission	Document
Jul 8, 2025	SUPPL -41	View Letter (PDF)
Apr 18, 2017	SUPPL -33	View Letter (PDF)
Mar 8, 2013	SUPPL -30	View Letter (PDF)
May 19, 2009	SUPPL -26	View Letter (PDF)
Jan 20, 2006	SUPPL -24	View Letter (PDF)
Jun 1, 2004	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — EQ 150MG BASE/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

Change History (3)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Colistimethate sodium (Coly-Mycin M) product type changed from prescription to discontinued in FDA records.

Old: RX

New: DISCN

MODIFIEDrs7/1/2026

Colistimethate sodium (Coly-Mycin M) removed from the Rx-to-OTC switch eligibility list, shifting from prescription-only to maintaining its current regulatory status per applicant PH Health's modification.

Old: Yes

New: No

MODIFIEDTE Code7/1/2026

Colistimethate sodium (Coly-Mycin M) therapeutic equivalence code changed from AP to a different rating by PH Health.

Old: AP