FDA Orange Book
Generic for Navelbine
Navelbine contains vinorelbine. 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 Navelbine is vinorelbine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Navelbine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 10MG BASE/ML | Discontinued | None | 5 | AP |
NDA 020388, held by PIERRE FABRE MEDICAMENT. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic vinorelbine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 075992 | AP (A-rated, therapeutically equivalent) | June 10, 2003 | EQ 10MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 076461 | AP (A-rated, therapeutically equivalent) | December 11, 2003 | EQ 10MG BASE/ML |
| ACTAVIS TOTOWA LLC | 078011 | AP (A-rated, therapeutically equivalent) | July 22, 2009 | EQ 10MG BASE/ML |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 091106 | AP (A-rated, therapeutically equivalent) | September 26, 2012 | EQ 10MG BASE/ML |
| DR REDDYS LABORATORIES LTD | 202017 | AP (A-rated, therapeutically equivalent) | September 12, 2013 | EQ 10MG BASE/ML |
Questions
Is there a generic for Navelbine?
Yes. The generic name for Navelbine is vinorelbine. 4 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 Navelbine?
The active ingredient in Navelbine is vinorelbine, 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.