← FDA DRUG APPROVALS

FDA NDA · NDA050108

COLY-MYCIN M

colistimethate

Sponsor: PH HEALTH

APPLICATION
NDA050108
TYPE
NDA
ORIGINAL APPROVAL
1970-06-04
LATEST ACTION
2025-07-03
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

COLY-MYCIN M · ReferenceDiscontinued
COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-07-03Labeling · Supplement 41 · standard — Letter ↗AP
2017-04-14Labeling · Supplement 33 · standard — Label ↗AP
2013-03-07Labeling · Supplement 30 · standard — Label ↗AP
2009-05-13Labeling · Supplement 26 · standard — Letter ↗AP
2006-01-12Labeling · Supplement 24 · standard — Label ↗AP
2002-12-20Labeling · Supplement 23 · standard — Letter ↗AP
2001-09-28Manufacturing (CMC) · Supplement 22AP
1999-11-26Labeling · Supplement 21 · standardAP
1994-04-28Manufacturing (CMC) · Supplement 20AP
1985-12-10Manufacturing (CMC) · Supplement 4AP
1983-04-11Manufacturing (CMC) · Supplement 3AP
1983-03-14Manufacturing (CMC) · Supplement 2AP
1982-10-07Labeling · Supplement 1AP
1981-10-23Manufacturing (CMC) · Supplement 19AP
1980-08-18Labeling · Supplement 18AP
1980-01-18Manufacturing (CMC) · Supplement 17AP
1979-08-31Labeling · Supplement 16AP
1978-12-08Manufacturing (CMC) · Supplement 15AP
1976-05-17Manufacturing (CMC) · Supplement 14AP
1975-09-11Manufacturing (CMC) · Supplement 13AP
1973-12-14Manufacturing (CMC) · Supplement 12AP
1972-06-05Manufacturing (CMC) · Supplement 9AP
1971-02-11Labeling · Supplement 8AP
1970-12-22Manufacturing (CMC) · Supplement 6AP
1970-12-19Labeling · Supplement 7AP
1970-08-17Manufacturing (CMC) · Supplement 5AP
1970-06-04UNKNOWN · Original · unknown — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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