Travoprost Ophthalmic Solution, 0.004%
These highlights do not include all the information needed to use TRAVOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for TRAVOPROST OPHTHALMIC SOLUTION. TRAVOPROST ophthalmic solution (ionic buffered solution) 0.004%, for topical ophthalmic useInitial U.S. Approval: 2001
Approved
Approval ID
00dc284f-fd96-423b-bb8f-b90ee13439bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Travoprost Ophthalmic Solution, 0.004%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9651
Application NumberANDA205050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Travoprost Ophthalmic Solution, 0.004%
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 14, 2020
FDA Product Classification
INGREDIENTS (9)
TRAVOPROSTActive
Quantity: 0.04 mg in 1 mL
Code: WJ68R08KX9
Classification: ACTIB
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ZINC CHLORIDEInactive
Code: 86Q357L16B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT