FDA Orange Book
Generic for Diprolene Af
Diprolene Af contains betamethasone dipropionate. 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 Diprolene Af is betamethasone dipropionate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Diprolene Af products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, augmented, topical | EQ 0.05% BASE | Discontinued | None | 3 | AB |
NDA 019555, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic betamethasone dipropionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 076215 | AB (A-rated, therapeutically equivalent) | December 9, 2003 | EQ 0.05% BASE |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076592 | AB (A-rated, therapeutically equivalent) | December 9, 2003 | EQ 0.05% BASE |
| SUN PHARMA CANADA INC | 076543 | AB (A-rated, therapeutically equivalent) | December 9, 2003 | EQ 0.05% BASE |
Questions
Is there a generic for Diprolene Af?
Yes. The generic name for Diprolene Af is betamethasone dipropionate. 3 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 Diprolene Af?
The active ingredient in Diprolene Af is betamethasone dipropionate, 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.