Xipere
These highlights do not include all the information needed to use XIPERE™ safely and effectively. See full prescribing information for XIPERE™. XIPERE™ (triamcinolone acetonide injectable suspension), for suprachoroidal use Initial U.S. Approval: 1957
Approved
Approval ID
c55c3521-a033-4683-9a57-3207f59a4029
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2021
Manufacturers
FDA
Clearside Biomedical, Inc.
DUNS: 029778767
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
triamcinolone acetonide
PRODUCT DETAILS
NDC Product Code71565-040
Application NumberNDA211950
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateDecember 21, 2021
Generic Nametriamcinolone acetonide
INGREDIENTS (11)
TRIAMCINOLONE ACETONIDEActive
Quantity: 40 mg in 1 mL
Code: F446C597KA
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT