FDA Orange Book
Generic for Jalyn
Jalyn contains dutasteride and tamsulosin. 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 Jalyn is dutasteride and tamsulosin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Jalyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.5MG;0.4MG | Marketed (Rx) | AB | 2 | AB |
NDA 022460, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dutasteride and tamsulosin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 207769 | AB (A-rated, therapeutically equivalent) | May 24, 2018 | 0.5MG;0.4MG |
| AUROBINDO PHARMA LTD | 213300 | AB (A-rated, therapeutically equivalent) | July 18, 2024 | 0.5MG;0.4MG |
Jalyn NDC codes
Questions
Is there a generic for Jalyn?
Yes. The generic name for Jalyn is dutasteride and tamsulosin. 2 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 Jalyn?
The active ingredient in Jalyn is dutasteride and tamsulosin, 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.