FDA Orange Book · active-ingredient family
Estazolam
Estazolam: 1 brand, 3 generics; first approved Dec 26, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- PROSOMRLDABBOTTNDA 01908019902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- ESTAZOLAMWATSON LABSANDA 07481819972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - ESTAZOLAMDR REDDYS LABS SAANDA 07492119972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - ESTAZOLAMNOVITIUM PHARMAANDA 07482619972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
36 yr 2 mo ago
Most recent approval
29 yr 5 mo ago
Approvals span 1990–1997 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Estazolam: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
