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 Olopatadine Hydrochloride Nasal Spray. Olopatadine Hydrochloride (olopatadine hydrochloride) Nasal Spray Initial U.S. Approval: 1996
Approved
Approval ID
6393e997-7080-4ce6-8a34-2f80b48f5a3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2016
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
olopatadine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61314-320
Application NumberNDA021861
Product Classification
M
Marketing Category
C73605
G
Generic Name
olopatadine hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateMay 23, 2016
FDA Product Classification
INGREDIENTS (8)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Olopatadine HydrochlorideActive
Quantity: 665 ug in 100 uL
Code: 2XG66W44KF
Classification: ACTIM