PATANASE
These highlights do not include all the information needed to use PATANASE® Nasal Spray safely and effectively. See full prescribing information for PATANASE Nasal Spray. PATANASE (olopatadine hydrochloride) Nasal Spray Initial U.S. Approval: 1996
Approved
Approval ID
24fb7339-f5a9-4d02-a492-43617729412b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6049
Application NumberNDA021861
Product Classification
M
Marketing Category
C73594
G
Generic Name
olopatadine hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateJanuary 16, 2012
FDA Product Classification
INGREDIENTS (8)
OLOPATADINE HYDROCHLORIDEActive
Quantity: 665 ug in 1 1
Code: 2XG66W44KF
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT