FDA Orange Book
Generic for Ablysinol
Ablysinol contains dehydrated alcohol. 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 Ablysinol is dehydrated alcohol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Ablysinol products the Orange Book lists.
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Ablysinol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intra-arterial | 99% (1ML) | Discontinued | None | 0 | None |
| solution, intra-arterial | 99% (5ML) | Marketed (Rx) | AP | 4 | AP |
NDA 207987, held by BPI LABS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dehydrated alcohol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 217845 | AP (A-rated, therapeutically equivalent) | June 23, 2025 | 99% (5ML) |
| BRECKENRIDGE PHARMACEUTICAL INC | 219444 | AP (A-rated, therapeutically equivalent) | June 23, 2025 | 99% (5ML) |
| XGEN PHARMACEUTICALS DJB INC | 219400 | AP (A-rated, therapeutically equivalent) | June 23, 2025 | 99% (5ML) |
| INGENUS PHARMACEUTICALS LLC | 219569 | AP (A-rated, therapeutically equivalent) | July 9, 2025 | 99% (5ML) |
Ablysinol NDC codes
Questions
Is there a generic for Ablysinol?
Yes. The generic name for Ablysinol is dehydrated alcohol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Ablysinol products the Orange Book lists.
What is the generic name for Ablysinol?
The active ingredient in Ablysinol is dehydrated alcohol, 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.