FDA Orange Book
Generic for Amikin
Amikin contains amikacin. 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 Amikin is amikacin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Amikin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 250MG BASE/ML | Discontinued | None | 6 | AP |
| injectable, injection | EQ 50MG BASE/ML | Discontinued | None | 1 | None |
NDA 050495, held by APOTHECON INC DIV BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amikacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MEITHEAL PHARMACEUTICALS INC | 064045 | AP (A-rated, therapeutically equivalent) | September 28, 1993 | EQ 250MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 063315 | AP (A-rated, therapeutically equivalent) | April 11, 1994 | EQ 250MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 063313 | None (No TE code listed) | April 11, 1994 | EQ 50MG BASE/ML |
| AVET LIFESCIENCES LTD | 204040 | AP (A-rated, therapeutically equivalent) | December 12, 2013 | EQ 250MG BASE/ML |
| FRESENIUS KABI USA LLC | 205604 | AP (A-rated, therapeutically equivalent) | December 9, 2015 | EQ 250MG BASE/ML |
| SAGENT PHARMACEUTICALS INC | 203323 | AP (A-rated, therapeutically equivalent) | May 12, 2016 | EQ 250MG BASE/ML |
| QILU PHARMACEUTICAL CO LTD | 218146 | AP (A-rated, therapeutically equivalent) | March 19, 2024 | EQ 250MG BASE/ML |
Questions
Is there a generic for Amikin?
Yes. The generic name for Amikin is amikacin. 6 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 Amikin?
The active ingredient in Amikin is amikacin, 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.