FDA Orange Book
Generic for Tobi
Tobi contains tobramycin. 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 Tobi is tobramycin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
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Tobi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | 300MG/5ML | Marketed (Rx) | AN | 9 | AN |
NDA 050753, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tobramycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 091589 | AN (A-rated, therapeutically equivalent) | October 10, 2013 | 300MG/5ML |
| HIKMA PHARMACEUTICALS USA INC | 201422 | AN (A-rated, therapeutically equivalent) | May 28, 2014 | 300MG/5ML |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 205501 | AN (A-rated, therapeutically equivalent) | July 13, 2015 | 300MG/5ML |
| LUPIN INC | 208964 | AN (A-rated, therapeutically equivalent) | March 22, 2017 | 300MG/5ML |
| DR REDDYS LABORATORIES SA | 207080 | AN (A-rated, therapeutically equivalent) | July 9, 2018 | 300MG/5ML |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 207136 | AN (A-rated, therapeutically equivalent) | December 26, 2019 | 300MG/5ML |
| ALKEM LABORATORIES LTD | 212848 | AN (A-rated, therapeutically equivalent) | April 1, 2021 | 300MG/5ML |
| MANKIND PHARMA LTD | 214478 | AN (A-rated, therapeutically equivalent) | June 30, 2023 | 300MG/5ML |
| MICRO LABS LTD | 217344 | AN (A-rated, therapeutically equivalent) | July 27, 2023 | 300MG/5ML |
Tobi NDC codes
Questions
Is there a generic for Tobi?
Yes. The generic name for Tobi is tobramycin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
What is the generic name for Tobi?
The active ingredient in Tobi is tobramycin, 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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