← FDA DRUG APPROVALS
FDA ANDA · ANDA212942
TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%
Sponsor: ALEMBIC
APPLICATION
ANDA212942
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-22
LATEST ACTION
2020-10-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION, GEL FORMING/DROPS
MARKETING STATUS
Prescription
Products
TIMOLOL MALEATEPrescription
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC
TIMOLOL MALEATEPrescription
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.