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FDA NDA · NDA217836

QLOSI

pilocarpine hydrochloride

Sponsor: ORASIS PHARMS

APPLICATION
NDA217836
TYPE
NDA
ORIGINAL APPROVAL
2023-10-17
LATEST ACTION
2023-10-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

QLOSI · ReferencePrescription
PILOCARPINE HYDROCHLORIDE 0.4% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2023-10-17Type 3 - New Dosage Form · Original · standardLetterAP
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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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