FDA Orange Book
Generic for Prosom
Prosom contains estazolam. 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 Prosom is estazolam. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Prosom products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Discontinued | None | 3 | AB |
| tablet, oral | 2MG | Discontinued | None | 3 | AB |
NDA 019080, held by ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic estazolam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 074826 | AB (A-rated, therapeutically equivalent) | July 3, 1997 | 1MG, 2MG |
| DR REDDYS LABORATORIES SA | 074921 | AB (A-rated, therapeutically equivalent) | July 10, 1997 | 1MG, 2MG |
| WATSON LABORATORIES INC | 074818 | AB (A-rated, therapeutically equivalent) | August 19, 1997 | 1MG, 2MG |
Questions
Is there a generic for Prosom?
Yes. The generic name for Prosom is estazolam. 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 Prosom?
The active ingredient in Prosom is estazolam, 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.