FDA Orange Book
Is there a generic for Miochol-e?
Miochol-e contains acetylcholine chloride. 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 Miochol-e (acetylcholine chloride).
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Miochol-e products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, ophthalmic | 20MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 020213, held by BAUSCH AND LOMB INC. 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 Miochol-e?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Miochol-e (acetylcholine chloride).
What is the generic name for Miochol-e?
The active ingredient in Miochol-e is acetylcholine chloride, 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.