OLOPATADINE HYDROCHLORIDE
Olapatadine Hydrochloride
Approved
Approval ID
9595068f-5a1c-9d7e-e053-2a95a90aaf8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2019
Manufacturers
FDA
Direct Rx
DUNS: 079254320
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 Code72189-053
Application NumberANDA204812
Product Classification
M
Marketing Category
C73584
G
Generic Name
OLOPATADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 23, 2019
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
OLOPATADINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 2XG66W44KF
Classification: ACTIM