FDA Orange Book
Generic for Sterane
Sterane contains prednisolone acetate. 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 Sterane is prednisolone acetate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 1 of the 2 Sterane products the Orange Book lists.
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Sterane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 25MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 5MG | Discontinued | None | 4 | BX, AB |
NDA 011446, 009996, held by PFIZER LABORATORIES DIV PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prednisolone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 215673 | AB (A-rated, therapeutically equivalent) | March 17, 2023 | 5MG |
| ZHEJIANG XIANJU PHARMACEUTICAL CO LTD | 218083 | AB (A-rated, therapeutically equivalent) | May 2, 2024 | 5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 080531 | BX (B-rated, not considered equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
| WATSON LABORATORIES INC | 080354 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
Questions
Is there a generic for Sterane?
Yes. The generic name for Sterane is prednisolone acetate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 1 of the 2 Sterane products the Orange Book lists.
What is the generic name for Sterane?
The active ingredient in Sterane is prednisolone acetate, 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.