OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE ophthalmic solution Initial U.S. Approval: 1996
Approved
Approval ID
7b36e554-d68a-47e0-bf3c-f4cfdc3746b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 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 Code62332-501
Application NumberANDA209919
Product Classification
M
Marketing Category
C73584
G
Generic Name
olopatadine hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 11, 2016
FDA Product Classification
INGREDIENTS (7)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
OLOPATADINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 2XG66W44KF
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT