FDA Orange Book
Generic for Coly-mycin M
Coly-mycin M contains colistimethate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Coly-mycin M is colistimethate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Coly-mycin M and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Coly-mycin M products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 150MG BASE/VIAL | Discontinued | None | 4 | AP |
NDA 050108, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic colistimethate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 065364 | AP (A-rated, therapeutically equivalent) | April 17, 2008 | EQ 150MG BASE/VIAL |
| AVET LIFESCIENCES LTD | 202359 | AP (A-rated, therapeutically equivalent) | September 28, 2012 | EQ 150MG BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 201365 | AP (A-rated, therapeutically equivalent) | February 19, 2014 | EQ 150MG BASE/VIAL |
| XELLIA PHARMACEUTICALS APS | 205356 | AP (A-rated, therapeutically equivalent) | May 29, 2015 | EQ 150MG BASE/VIAL |
Coly-mycin M NDC codes
Questions
Is there a generic for Coly-mycin M?
Yes. The generic name for Coly-mycin M is colistimethate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Coly-mycin M?
The active ingredient in Coly-mycin M is colistimethate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.