FDA Orange Book
Generic for Aredia
Aredia contains pamidronate. 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 Aredia is pamidronate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Aredia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 30MG/VIAL | Discontinued | None | 2 | AP |
| injectable, injection | 60MG/VIAL | Discontinued | None | 1 | None |
| injectable, injection | 90MG/VIAL | Discontinued | None | 2 | AP |
NDA 020036, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pamidronate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 075290 | AP (A-rated, therapeutically equivalent) | April 30, 2001 | 30MG/VIAL, 90MG/VIAL |
| AREVA PHARMACEUTICALS INC | 077433 | AP (A-rated, therapeutically equivalent) | November 26, 2008 | 30MG/VIAL, 60MG/VIAL, 90MG/VIAL |
Questions
Is there a generic for Aredia?
Yes. The generic name for Aredia is pamidronate. 2 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 Aredia?
The active ingredient in Aredia is pamidronate, 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.