FDA Orange Book · active-ingredient family
Carteolol hydrochloride
Carteolol hydrochloride: 2 brands, 3 generics; first approved Dec 28, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
3
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- OCUPRESSRLDNOVARTISNDA 0199721990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued — - ABBVIENDA 01920419883 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- CARTEOLOL HYDROCHLORIDEAPOTEX INCANDA 0760972002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued — - CARTEOLOL HYDROCHLORIDEBAUSCH AND LOMBANDA 0755462000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued — - CARTEOLOL HYDROCHLORIDERSSANDOZANDA 0754762000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx —
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
38 yr 2 mo ago
Most recent approval
24 yr 11 mo ago
Approvals span 1988–2002 across 5 FDA applications.
Brand (NDA) 240%
Generic (ANDA) 360%
Carteolol 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.
