FDA Orange Book
Generic for Ambisome
Ambisome contains amphotericin b. 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 Ambisome is amphotericin b. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ambisome products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, liposomal, injection | 50MG/VIAL | Marketed (Rx) | AB | 4 | AB |
NDA 050740, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amphotericin b
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA INDUSTRIES LTD | 212514 | AB (A-rated, therapeutically equivalent) | December 14, 2021 | 50MG/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 214010 | AB (A-rated, therapeutically equivalent) | November 17, 2022 | 50MG/VIAL |
| AVET LIFESCIENCES PRIVATE LTD | 215354 | AB (A-rated, therapeutically equivalent) | June 2, 2025 | 50MG/VIAL |
| MYLAN LABORATORIES LTD | 212967 | AB (A-rated, therapeutically equivalent) | June 30, 2025 | 50MG/VIAL |
Questions
Is there a generic for Ambisome?
Yes. The generic name for Ambisome is amphotericin b. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Ambisome?
The active ingredient in Ambisome is amphotericin b, 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.