FDA Orange Book · active-ingredient family
Apraclonidine hydrochloride
Apraclonidine hydrochloride: 2 brands, 1 generic; first approved Dec 31, 1987; generic available.
Generic available
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- HARROW EYENDA 0202581993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - HARROW EYENDA 0197791987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1% BASE SOLUTION/DROPS OPHTHALMIC Rx —
Generic (ANDA) products (1)
Abbreviated applications
- APRACLONIDINE HYDROCHLORIDERISINGANDA 0777642009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE 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
39 yr 2 mo ago
Most recent approval
17 yr 8 mo ago
Approvals span 1987–2009 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Apraclonidine 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.
