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YUTIQ

These highlights do not include all the information needed to use YUTIQ safely and effectively. See full prescribing information for YUTIQ. YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection Initial U.S. Approval: 1963

Approved
Approval ID

43ba66d9-653d-48b9-9914-b0a50b68b79a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2023

Manufacturers
FDA

EyePoint Pharmaceuticals, Inc

DUNS: 968003785

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

fluocinolone acetonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71879-136
Application NumberNDA210331
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationINTRAOCULAR
Effective DateDecember 13, 2023
FDA Product Classification

INGREDIENTS (3)

POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLUOCINOLONE ACETONIDEActive
Quantity: 0.18 mg in 1 1
Code: 0CD5FD6S2M
Classification: ACTIB

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YUTIQ - FDA Drug Approval Details