Travoprost Ophthalmic Solution USP, 0.004%
These highlights do not include all the information needed to use TRAVOPROST OPHTHALMIC SOLUTION USP, 0.004% safely and effectively. See full prescribing information for TRAVOPROST OPHTHALMIC SOLUTION USP, 0.004%. TRAVOPROST ophthalmic solution USP 0.004% Initial U.S. Approval: 2001
Approved
Approval ID
be3bdc10-b5eb-4b4b-9a00-1f8c03ccb3b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2022
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Travoprost Ophthalmic Solution USP, 0.004%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-510
Application NumberANDA210458
Product Classification
M
Marketing Category
C73584
G
Generic Name
Travoprost Ophthalmic Solution USP, 0.004%
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 20, 2019
FDA Product Classification
INGREDIENTS (10)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
TRAVOPROSTActive
Quantity: 0.04 mg in 1 mL
Code: WJ68R08KX9
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT