LATANOPROST
These highlights do not include all the information needed to use Latanoprost Ophthalmic Solution safely and effectively. See full prescribing information for Latanoprost Ophthalmic Solution. Latanoprost Ophthalmic Solution 0.005% Initial U.S. Approval:1996
Approved
Approval ID
891a5db6-ca9b-48f0-b3c6-7cd56e310c5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2019
Manufacturers
FDA
FDC Limited
DUNS: 650441301
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
latanoprost
PRODUCT DETAILS
NDC Product Code55545-1010
Application NumberANDA202442
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateNovember 29, 2019
Generic Namelatanoprost
INGREDIENTS (5)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
LATANOPROSTActive
Quantity: 50 ug in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB