FDA Orange Book
Generic for Eloxatin
Eloxatin contains oxaliplatin. 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 Eloxatin is oxaliplatin. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Eloxatin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 100MG/20ML (5MG/ML) | Discontinued | None | 10 | AP |
| injectable, intravenous | 100MG/VIAL | Discontinued | None | 3 | AP |
| injectable, intravenous | 200MG/40ML (5MG/ML) | Discontinued | None | 1 | None |
| injectable, intravenous | 50MG/10ML (5MG/ML) | Discontinued | None | 10 | AP |
| injectable, intravenous | 50MG/VIAL | Discontinued | None | 3 | AP |
NDA 021759, 021492, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxaliplatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA WORLDWIDE PTY | 078813 | AP (A-rated, therapeutically equivalent) | August 7, 2009 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| FRESENIUS KABI USA LLC | 078819 | AP (A-rated, therapeutically equivalent) | June 2, 2010 | 100MG/VIAL, 50MG/VIAL |
| FRESENIUS KABI USA LLC | 078811 | AP (A-rated, therapeutically equivalent) | June 10, 2010 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| SANDOZ INC | 078817 | AP (A-rated, therapeutically equivalent) | January 24, 2011 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| MYLAN LABORATORIES LTD | 091358 | AP (A-rated, therapeutically equivalent) | August 7, 2012 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| QILU PHARMACEUTICAL HAINAN CO LTD | 204616 | AP (A-rated, therapeutically equivalent) | May 11, 2016 | 100MG/VIAL, 50MG/VIAL |
| QILU PHARMACEUTICAL HAINAN CO LTD | 204368 | AP (A-rated, therapeutically equivalent) | June 7, 2016 | 100MG/20ML (5MG/ML), 200MG/40ML (5MG/ML), 50MG/10ML (5MG/ML) |
| GLAND PHARMA LTD | 207325 | AP (A-rated, therapeutically equivalent) | February 10, 2017 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| ACCORD HEALTHCARE INC | 207474 | AP (A-rated, therapeutically equivalent) | March 21, 2017 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| GLAND PHARMA LTD | 207385 | AP (A-rated, therapeutically equivalent) | May 23, 2017 | 100MG/VIAL, 50MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 217348 | AP (A-rated, therapeutically equivalent) | January 11, 2024 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| HETERO LABS LTD UNIT VI | 217925 | AP (A-rated, therapeutically equivalent) | January 27, 2025 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 219765 | AP (A-rated, therapeutically equivalent) | January 15, 2026 | 100MG/20ML (5MG/ML), 50MG/10ML (5MG/ML) |
Questions
Is there a generic for Eloxatin?
Yes. The generic name for Eloxatin is oxaliplatin. 10 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 Eloxatin?
The active ingredient in Eloxatin is oxaliplatin, 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.