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%, for topical ophthalmic use Initial U.S. Approval: 1996
Approved
Approval ID
19cdfef0-b770-4758-8f59-1769e4b6119c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 11, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-872
Application NumberANDA206519
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateApril 11, 2023
Generic NameLatanoprost
INGREDIENTS (6)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LATANOPROSTActive
Quantity: 50 ug in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT