FDA Orange Book

Is there a generic for Bal?

Bal contains dimercaprol. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Bal (dimercaprol).

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Bal products in the Orange Book

Bal products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection10%Marketed (Rx)None0None

NDA 005939, held by PROVEPHARM SAS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Questions

Is there a generic for Bal?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Bal (dimercaprol).

What is the generic name for Bal?

The active ingredient in Bal is dimercaprol, 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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