LASTACAFT
These highlights do not include all the information needed to use LASTACAFT™ safely and effectively. See full prescribing information for LASTACAFT™. LASTACAFT™ (alcaftadine ophthalmic solution) 0.25%Initial U.S. Approval: 2010
Approved
Approval ID
c192fecc-046d-4905-868f-b8200320309c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alcaftadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6294
Application NumberNDA022134
Product Classification
M
Marketing Category
C73594
G
Generic Name
alcaftadine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 22, 2011
FDA Product Classification
INGREDIENTS (8)
alcaftadineActive
Quantity: 2.5 mg in 1 mL
Code: 7Z8O94ECSX
Classification: ACTIB
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT