FDA Orange Book · active-ingredient family
Dorzolamide hydrochloride
Dorzolamide hydrochloride: 1 brand, 14 generics; first approved Dec 09, 1994; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
14
Listed patents
0
Presentations
15
Brand (NDA) products
Originator applications
- TRUSOPTRLDMSD SUB MERCKNDA 0204081994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- DORZOLAMIDE HYDROCHLORIDESOMERSET THERAPS LLCANDA 2150042025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDEGLANDANDA 2156602022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDERSMICRO LABSANDA 2047782019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDEALEMBICANDA 2126392019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDEFDC LTDANDA 2052942019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDEREGCON HOLDINGSANDA 2020532014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDEZAMBON SPAANDA 0910342013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - DORZOLAMIDE HYDROCHLORIDEAM REGENTANDA 0791862009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - DORZOLAMIDE HYDROCHLORIDEBAUSCH AND LOMBANDA 0901432009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDESANDOZANDA 0789812009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDETEVA PHARMSANDA 0787562008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - DORZOLAMIDE HYDROCHLORIDESANDOZANDA 0787482008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - DORZOLAMIDE HYDROCHLORIDEHIKMAANDA 0778462008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - DORZOLAMIDE HYDROCHLORIDERUBICON RESEARCHANDA 0783952008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2% 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
32 yr 2 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 1994–2025 across 15 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1493%
Dorzolamide 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.
