OLOPATADINE HYDROCHLORIDE
1161 OLOPATADINE HCL
Approved
Approval ID
91466fe8-f0cd-084d-e053-2a95a90ae655
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 29, 2019
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code76519-1161
Application NumberANDA206306
Product Classification
M
Marketing Category
C73584
G
Generic Name
OLOPATADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 29, 2019
FDA Product Classification
INGREDIENTS (1)
OLOPATADINE HYDROCHLORIDEActive
Quantity: 1.11 mg in 1 mL
Code: 2XG66W44KF
Classification: ACTIM