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FDA NDA · NDA212520

UPNEEQ

oxymetazoline hydrochloride ophthalmic

Sponsor: RVL PHARMS

APPLICATION
NDA212520
TYPE
NDA
ORIGINAL APPROVAL
2020-07-08
LATEST ACTION
2021-05-05
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

UPNEEQ · ReferencePrescription
OXYMETAZOLINE HYDROCHLORIDE 0.1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-05-05Labeling · Supplement 4 · standard — Label ↗AP
2020-08-14Labeling · Supplement 2 · standard — Label ↗AP
2020-07-08UNKNOWN · Original · standard — Label ↗AP
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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