Olopatadine Hydrochloride
These highlights do not include all the information needed to use OLOPATADINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for OLOPADATINE HYDROCHLORIDE NASAL SPRAY.OLOPATADINE HYDROCHLORIDE Nasal Spray, for intranasal use Initial U.S. Approval: 1996
Approved
Approval ID
f42d26f8-c583-411b-b17f-b3ca9eaba7a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Olopatadine Hydrochloride Nasal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-943
Application NumberANDA213757
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olopatadine Hydrochloride Nasal
Product Specifications
Route of AdministrationNASAL
Effective DateJanuary 11, 2023
FDA Product Classification
INGREDIENTS (8)
OLOPATADINE HYDROCHLORIDEActive
Quantity: 665 ug in 1 1
Code: 2XG66W44KF
Classification: ACTIM
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT