Brimonidine tartrate; timolol maleate
Brimonidine tartrate; timolol maleate: 1 brand, 12 generics; first approved Oct 30, 2007; generic available.
Generic available: 12 ANDA applications approved.
Brand (NDA) products
- ABBVIENDA 0213982007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB
Generic (ANDA) products (12)
- SABA ILAC SANAYIVEANDA 2179342026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - GLANDANDA 2191662026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - CAPLINANDA 2190932025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - AMNEALANDA 2172882024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - SOMERSETANDA 2161142024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - GLENMARK PHARMS LTDANDA 2149872024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - ALEMBICANDA 2152302023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - UPSHER SMITH LABSANDA 2155982022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - SENTISSANDA 0910862022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - REGCON HOLDINGSANDA 2019492022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - APOTEXANDA 0914422022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB - SANDOZANDA 0910872022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2%;EQ 0.5% BASE SOLUTION/DROPS OPHTHALMIC Rx AB
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 2007–2026 across 13 FDA applications.
Brimonidine tartrate; timolol maleate: 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.
