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FDA ANDA · ANDA209995

OLOPATADINE HYDROCHLORIDE

Sponsor: EUGIA PHARMA

APPLICATION
ANDA209995
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-04
LATEST ACTION
2020-07-15
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

2020-07-15Labeling · Supplement 1 · standardAP
2019-04-04UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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