FDA Orange Book
Generic for Gris-peg
Gris-peg contains griseofulvin ultramicrosize. 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 Gris-peg is griseofulvin ultramicrosize. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Gris-peg products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 125MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 250MG | Marketed (Rx) | AB | 4 | AB |
NDA 050475, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic griseofulvin ultramicrosize
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SIGMAPHARM LABORATORIES LLC | 202545 | AB (A-rated, therapeutically equivalent) | October 22, 2012 | 125MG, 250MG |
| MOUNTAIN LLC | 204371 | AB (A-rated, therapeutically equivalent) | January 9, 2014 | 125MG, 250MG |
| SANDOZ INC | 202805 | AB (A-rated, therapeutically equivalent) | December 26, 2018 | 125MG, 250MG |
| CHARTWELL RX SCIENCES LLC | 061996 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 125MG, 250MG |
Questions
Is there a generic for Gris-peg?
Yes. The generic name for Gris-peg is griseofulvin ultramicrosize. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Gris-peg?
The active ingredient in Gris-peg is griseofulvin ultramicrosize, 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.