FDA Orange Book
Generic for Florone E
Florone E contains diflorasone diacetate. 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 Florone E is diflorasone diacetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: BX.
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Florone E products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Discontinued | None | 1 | BX |
NDA 019259, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diflorasone diacetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 075508 | BX (B-rated, not considered equivalent) | April 24, 2000 | 0.05% |
Questions
Is there a generic for Florone E?
Yes. The generic name for Florone E is diflorasone diacetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: BX.
What is the generic name for Florone E?
The active ingredient in Florone E is diflorasone diacetate, 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.