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FDA ANDA · ANDA078350

OLOPATADINE HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
ANDA078350
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-07
LATEST ACTION
2020-07-02
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

2020-07-02Labeling · Supplement 7 · standardAP
2015-12-07OriginalLetterAP
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