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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-872
Application NumberANDA206519
Product Classification
M
Marketing Category
C73584
G
Generic Name
Latanoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 11, 2023
FDA Product Classification
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