FDA Orange Book
Is there a generic for Coly-mycin S?
Coly-mycin S contains colistin, neomycin, thonzonium bromide and hydrocortisone acetate. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Coly-mycin S (colistin, neomycin, thonzonium bromide and hydrocortisone acetate).
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Coly-mycin S products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, otic | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | Marketed (Rx) | None | 0 | None |
| suspension, oral | EQ 25MG BASE/5ML | Discontinued | None | 0 | None |
NDA 050356, 050355, 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.
Coly-mycin S NDC codes
Questions
Is there a generic for Coly-mycin S?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Coly-mycin S (colistin, neomycin, thonzonium bromide and hydrocortisone acetate).
What is the generic name for Coly-mycin S?
The active ingredient in Coly-mycin S is colistin, neomycin, thonzonium bromide and hydrocortisone acetate, 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.