← FDA DRUG APPROVALS
FDA ANDA · ANDA209619
OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION
olopatadine hydrochloride ophthalmic
Sponsor: GLAND
APPLICATION
ANDA209619
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-02
LATEST ACTION
2020-05-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter
Products
OLOPATADINE HYDROCHLORIDEOver-the-counter
OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2020-05-07Labeling · Supplement 1 · standardAP
2019-08-02UNKNOWN · Original · standardAP
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.