FDA Orange Book
Generic for Lymphazurin
Lymphazurin contains isosulfan blue. 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 Lymphazurin is isosulfan blue. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Lymphazurin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 50MG/5ML (10MG/ML) | Discontinued | None | 7 | AP |
NDA 018310, held by COVIDIEN. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic isosulfan blue
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN INSTITUTIONAL LLC | 090874 | AP (A-rated, therapeutically equivalent) | July 20, 2010 | 50MG/5ML (10MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 206831 | AP (A-rated, therapeutically equivalent) | February 2, 2016 | 50MG/5ML (10MG/ML) |
| SABA ILAY SANAYI VE TICARET AS | 210714 | AP (A-rated, therapeutically equivalent) | January 16, 2019 | 50MG/5ML (10MG/ML) |
| SOMERSET THERAPEUTICS LLC | 210558 | AP (A-rated, therapeutically equivalent) | July 12, 2019 | 50MG/5ML (10MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 213130 | AP (A-rated, therapeutically equivalent) | November 3, 2021 | 50MG/5ML (10MG/ML) |
| MSN LABORATORIES PRIVATE LTD | 216090 | AP (A-rated, therapeutically equivalent) | September 16, 2022 | 50MG/5ML (10MG/ML) |
| AMERICAN REGENT INC | 210294 | AP (A-rated, therapeutically equivalent) | May 17, 2023 | 50MG/5ML (10MG/ML) |
Questions
Is there a generic for Lymphazurin?
Yes. The generic name for Lymphazurin is isosulfan blue. 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 Lymphazurin?
The active ingredient in Lymphazurin is isosulfan blue, 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.