FDA Orange Book · active-ingredient family
Levobunolol hydrochloride
Levobunolol hydrochloride: 2 brands, 8 generics; first approved Dec 19, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
8
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
Generic (ANDA) products (8)
Abbreviated applications
- LEVOBUNOLOL HYDROCHLORIDEAPOTEX INCANDA 0754732000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC Discontinued — - LEVOBUNOLOL HYDROCHLORIDEAPOTEX INCANDA 0754752000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued — - EPIC PHARMA LLCANDA 0747791996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC Discontinued — - EPIC PHARMA LLCANDA 0747801996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued — - LEVOBUNOLOL HYDROCHLORIDEALCON LABS INCANDA 0748511996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC Discontinued — - LEVOBUNOLOL HYDROCHLORIDECHARTWELL RXANDA 0748501996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued — - LEVOBUNOLOL HYDROCHLORIDEBAUSCH AND LOMBANDA 0743071994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION/DROPS OPHTHALMIC Discontinued — - LEVOBUNOLOL HYDROCHLORIDEBAUSCH AND LOMB INCANDA 0743261994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Rx AT
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 5 mo ago
Most recent approval
26 yr 7 mo ago
Approvals span 1985–2000 across 10 FDA applications.
Brand (NDA) 220%
Generic (ANDA) 880%
Levobunolol 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.
