FDA Orange Book · active-ingredient family
Betaxolol hydrochloride
Betaxolol hydrochloride: 3 brands, 6 generics; first approved Aug 30, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
6
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- NOVARTISNDA 0198451989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25% BASE SUSPENSION/DROPS OPHTHALMIC Rx — - SANDOZNDA 0192701985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - SANOFI AVENTIS USNDA 01950719892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- BETAXOLOL HYDROCHLORIDECHARTWELL RXANDA 0786942009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - BETAXOLOL HYDROCHLORIDEKVK TECHANDA 07896220082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - BETAXOLOL HYDROCHLORIDEEUROFARMAANDA 0756302001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - BETAXOLOL HYDROCHLORIDEAPOTEX INCANDA 0754462000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - BETAXOLOL HYDROCHLORIDEPHARMOBEDIENTANDA 0753862000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - BETAXOLOL HYDROCHLORIDEEPIC PHARMAANDA 07554119992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG 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
41 yr 7 mo ago
Most recent approval
17 yr ago
Approvals span 1985–2009 across 9 FDA applications.
Brand (NDA) 333%
Generic (ANDA) 667%
Betaxolol 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.
