FDA Orange Book
Generic for Garamycin
Garamycin contains gentamicin. 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 Garamycin is gentamicin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 2 of the 3 Garamycin products the Orange Book lists.
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Garamycin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intrathecal | EQ 2MG BASE/ML | Discontinued | None | 0 | None |
| ointment, ophthalmic | EQ 0.3% BASE | Discontinued | None | 1 | None |
| solution/drops, ophthalmic | EQ 0.3% BASE | Discontinued | None | 2 | AT |
NDA 050505, 050425, 050039, held by SCHERING CORP SUB SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic gentamicin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 064048 | AT (A-rated, therapeutically equivalent) | May 11, 1994 | EQ 0.3% BASE |
| SCIEGEN PHARMACEUTICALS INC | 065024 | None (No TE code listed) | July 30, 2004 | EQ 0.3% BASE |
| SANDOZ INC | 062196 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 0.3% BASE |
Questions
Is there a generic for Garamycin?
Yes. The generic name for Garamycin is gentamicin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 2 of the 3 Garamycin products the Orange Book lists.
What is the generic name for Garamycin?
The active ingredient in Garamycin is gentamicin, 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.