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FDA NDA · NDA210821

TETRACAINE HYDROCHLORIDE

Sponsor: BAUSCH LOMB IRELAND

APPLICATION
NDA210821
TYPE
NDA
ORIGINAL APPROVAL
2019-03-12
LATEST ACTION
2022-02-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TETRACAINE HYDROCHLORIDE · ReferencePrescription
TETRACAINE HYDROCHLORIDE 0.5% · SOLUTION · OPHTHALMIC

Approval history

2022-02-22Labeling · Supplement 5 · standard — Letter ↗AP
2019-03-12Type 5 - New Formulation or New Manufacturer · 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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