FDA Orange Book
Generic for Polytrim
Polytrim contains polymyxin b and trimethoprim. 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 Polytrim is polymyxin b and trimethoprim. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Polytrim products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 10,000 UNITS/ML;EQ 1MG BASE/ML | Discontinued | None | 4 | AT |
NDA 050567, held by ALLERGAN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic polymyxin b and trimethoprim
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 064120 | AT (A-rated, therapeutically equivalent) | February 14, 1997 | 10,000 UNITS/ML;EQ 1MG BASE/ML |
| SANDOZ INC | 064211 | AT (A-rated, therapeutically equivalent) | April 13, 1998 | 10,000 UNITS/ML;EQ 1MG BASE/ML |
| EPIC PHARMA LLC | 065006 | AT (A-rated, therapeutically equivalent) | December 17, 1998 | 10,000 UNITS/ML;EQ 1MG BASE/ML |
| SOMERSET THERAPEUTICS LLC | 211572 | AT (A-rated, therapeutically equivalent) | August 5, 2024 | 10,000 UNITS/ML;EQ 1MG BASE/ML |
Questions
Is there a generic for Polytrim?
Yes. The generic name for Polytrim is polymyxin b and trimethoprim. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Polytrim?
The active ingredient in Polytrim is polymyxin b and trimethoprim, 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.