FDA Orange Book · active-ingredient family
Ethambutol hydrochloride
Ethambutol hydrochloride: 1 brand, 3 generics; first approved Nov 30, 1999; 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
9
Brand (NDA) products
Originator applications
- MYAMBUTOLRLDKANCHAN HLTHCARENDA 016320—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- ETHAMBUTOL HYDROCHLORIDELUPINANDA 07893920092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB - ETHAMBUTOL HYDROCHLORIDEBARRANDA 0760572001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - ETHAMBUTOL HYDROCHLORIDEEPIC PHARMA LLCANDA 07509519992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 400MG 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
27 yr 1 mo ago
Most recent approval
17 yr 5 mo ago
Approvals span 1999–2009 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Ethambutol hydrochloride: 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.
