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FDA Approval

YUTIQ

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 13, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fluocinolone acetonide(0.18 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

EyePoint Pharmaceuticals, Inc

EyePoint Pharmaceuticals, Inc

968003785

Products1

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

YUTIQ

Product Details

NDC Product Code
71879-136
Application Number
NDA210331
Marketing Category
NDA (C73594)
Route of Administration
INTRAOCULAR
Effective Date
December 13, 2023
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 0CD5FD6S2MClass: ACTIBQuantity: 0.18 mg in 1 1
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