FDA Orange Book
Is there a generic for Phospholine Iodide?
Phospholine Iodide contains echothiophate iodide. 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 Phospholine Iodide (echothiophate iodide).
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Phospholine Iodide products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, ophthalmic | 0.03% | Discontinued | None | 0 | None |
| for solution, ophthalmic | 0.06% | Discontinued | None | 0 | None |
| for solution, ophthalmic | 0.125% | Marketed (Rx) | None | 0 | None |
| for solution, ophthalmic | 0.25% | Discontinued | None | 0 | None |
NDA 011963, held by FERA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Questions
Is there a generic for Phospholine Iodide?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Phospholine Iodide (echothiophate iodide).
What is the generic name for Phospholine Iodide?
The active ingredient in Phospholine Iodide is echothiophate iodide, 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.