Cyclopentolate hydrochloride
Cyclopentolate hydrochloride: 0 brands, 13 generics; first approved Feb 25, 1983; generic available.
Generic available: 13 ANDA applications approved.
Generic (ANDA) products (13)
- CYCLOPENTOLATE HYDROCHLORIDESCIEGEN PHARMSANDA 2059372015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued — - RISINGANDA 0401641997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT - RISINGANDA 0401651997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SOLUTION/DROPS OPHTHALMIC Rx AT - BAUSCH AND LOMB INCANDA 0400751994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT - CYCLOPENTOLATE HYDROCHLORIDEALCON PHARMS LTDANDA 0891621991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued — - PHARMAFAIRANDA 0886431987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Discontinued — - PHARMAFAIRANDA 0881501983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued — - EPIC PHARMA LLCANDA 085555—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued — - ALCON LABS INCANDA 084109—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION/DROPS OPHTHALMIC Rx — - ALCON LABS INCANDA 084110—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Rx AT - ALCON LABS INCANDA 084108—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SOLUTION/DROPS OPHTHALMIC Rx AT - CYCLOPENTOLATE HYDROCHLORIDESOLA BARNES HINDANDA 084150—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued — - CYCLOPENTOLATE HYDROCHLORIDESOLA BARNES HINDANDA 084863—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION/DROPS OPHTHALMIC Discontinued —
Listed patents
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
Approvals span 1983–2015 across 13 FDA applications.
Cyclopentolate 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.
