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FDA Approval

XDEMVY

CompanyTarsus Pharmaceuticals, Inc. (DUNS: 081222566)

Effective Date

July 26, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lotilaner(2.5 mg in 1 mL)

Products (1)

XDEMVY

NDC Product Code

81942-125

Application Number

NDA217603

Marketing Category

NDA (C73594)

Route of Administration

OPHTHALMIC

Effective Date

July 26, 2023

Ingredients

LotilanerActive

Code: HEH4938D7KClass: ACTIBQuantity: 2.5 mg in 1 mL

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