FDA Orange Book
Generic for Clolar
Clolar contains clofarabine. 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 Clolar is clofarabine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Clolar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 20MG/20ML (1MG/ML) | Discontinued | None | 7 | AP |
NDA 021673, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clofarabine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 208857 | AP (A-rated, therapeutically equivalent) | November 6, 2017 | 20MG/20ML (1MG/ML) |
| DR REDDYS LABORATORIES LTD | 205375 | AP (A-rated, therapeutically equivalent) | November 6, 2017 | 20MG/20ML (1MG/ML) |
| MSN LABORATORIES PRIVATE LTD | 209775 | AP (A-rated, therapeutically equivalent) | December 6, 2017 | 20MG/20ML (1MG/ML) |
| GLAND PHARMA LTD | 207831 | AP (A-rated, therapeutically equivalent) | October 31, 2018 | 20MG/20ML (1MG/ML) |
| ACCORD HEALTHCARE INC | 212034 | AP (A-rated, therapeutically equivalent) | February 22, 2019 | 20MG/20ML (1MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 213461 | AP (A-rated, therapeutically equivalent) | October 23, 2020 | 20MG/20ML (1MG/ML) |
| SCINOPHARM TAIWAN LTD | 216233 | AP (A-rated, therapeutically equivalent) | January 3, 2025 | 20MG/20ML (1MG/ML) |
Questions
Is there a generic for Clolar?
Yes. The generic name for Clolar is clofarabine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Clolar?
The active ingredient in Clolar is clofarabine, 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.