FDA Orange Book

Generic for Pred Forte

Pred Forte 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 Pred Forte is prednisolone acetate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Pred Forte products in the Orange Book

Pred Forte products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension/drops, ophthalmic1%Marketed (Rx)AB3AB

NDA 017011, held by ABBVIE 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

Approved generic versions of Pred Forte
CompanyANDATE codeApprovedStrengths
LUPIN LTD216935AB (A-rated, therapeutically equivalent)August 2, 20241%
AMNEAL EU LTD218256AB (A-rated, therapeutically equivalent)June 11, 20251%
UPSHER SMITH LABORATORIES LLC212778AB (A-rated, therapeutically equivalent)September 28, 20261%

Pred Forte NDC codes

Questions

Is there a generic for Pred Forte?

Yes. The generic name for Pred Forte is prednisolone acetate. 3 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 Pred Forte?

The active ingredient in Pred Forte 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.

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