OLOPATADINE HYDROCHLORIDE
These highlights do not include all the information needed to use OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION. OLOPATADINE HYDROCHLORIDE ophthalmic solution Initial U.S. Approval: 1996
Approved
Approval ID
dbcdf10c-5adb-4d48-97ce-f4b82c6bc77d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2019
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.
olopatadine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-502
Application NumberANDA209420
Product Classification
M
Marketing Category
C73584
G
Generic Name
olopatadine hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 29, 2019
FDA Product Classification
INGREDIENTS (9)
OLOPATADINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 2XG66W44KF
Classification: ACTIM
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT