FDA Orange Book
Generic for Desowen
Desowen contains desonide. 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 Desowen is desonide. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Desowen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Marketed (Rx) | AB | 4 | AB |
NDA 019048, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic desonide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 073548 | AB (A-rated, therapeutically equivalent) | June 30, 1992 | 0.05% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 074027 | AB (A-rated, therapeutically equivalent) | September 28, 1992 | 0.05% |
| CADILA HEALTHCARE LTD | 210198 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 214396 | AB (A-rated, therapeutically equivalent) | December 8, 2022 | 0.05% |
Desowen NDC codes
Questions
Is there a generic for Desowen?
Yes. The generic name for Desowen is desonide. 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 Desowen?
The active ingredient in Desowen is desonide, 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.