XDEMVY
These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
Approved
Approval ID
ccd9e37c-654e-4e84-8c85-6523457df979
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2023
Manufacturers
FDA
Tarsus Pharmaceuticals, Inc.
DUNS: 081222566
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lotilaner ophthalmic solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81942-125
Application NumberNDA217603
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lotilaner ophthalmic solution
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 26, 2023
FDA Product Classification
INGREDIENTS (1)
LotilanerActive
Quantity: 2.5 mg in 1 mL
Code: HEH4938D7K
Classification: ACTIB