FDA Orange Book
Generic for An-sulfur Colloid
An-sulfur Colloid contains technetium tc-99m sulfur colloid kit. 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 An-sulfur Colloid is technetium tc-99m sulfur colloid kit. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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An-sulfur Colloid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, injection, oral | N/A | Marketed (Rx) | AP | 1 | AP |
NDA 017858, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic technetium tc-99m sulfur colloid kit
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA | 213516 | AP (A-rated, therapeutically equivalent) | November 9, 2023 | N/A |
Questions
Is there a generic for An-sulfur Colloid?
Yes. The generic name for An-sulfur Colloid is technetium tc-99m sulfur colloid kit. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for An-sulfur Colloid?
The active ingredient in An-sulfur Colloid is technetium tc-99m sulfur colloid kit, 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.