FDA Orange Book
Generic for Acular Preservative Free
Acular Preservative Free contains ketorolac. 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 Acular Preservative Free is ketorolac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Acular Preservative Free products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.5% | Discontinued | None | 4 | AT |
NDA 020811, held by ALLERGAN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ketorolac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 076109 | AT (A-rated, therapeutically equivalent) | November 5, 2009 | 0.5% |
| SANDOZ INC | 076583 | AT (A-rated, therapeutically equivalent) | November 5, 2009 | 0.5% |
| MICRO LABS LTD INDIA | 203410 | AT (A-rated, therapeutically equivalent) | April 5, 2019 | 0.5% |
| CAPLIN STERILES LTD | 218204 | AT (A-rated, therapeutically equivalent) | March 26, 2024 | 0.5% |
Questions
Is there a generic for Acular Preservative Free?
Yes. The generic name for Acular Preservative Free is ketorolac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Acular Preservative Free?
The active ingredient in Acular Preservative Free is ketorolac, 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.