APPLICATION
ANDA209420
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-29
LATEST ACTION
2021-01-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter
Products
OLOPATADINE HYDROCHLORIDEOver-the-counter
OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2021-01-25Labeling · Supplement 1 · standardAP
2019-04-29UNKNOWN · 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.
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