OLOPATADINE HYDROCHLORIDE
OLOPATADINE Hydrochloride Ophthalmic Solution USP, 0.1%Somerset Therapeutics, LLC
Approved
Approval ID
c8c44b45-b69b-4ba9-bc4f-ce43e260a4b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-0510
Application NumberANDA206306
Product Classification
M
Marketing Category
C73584
G
Generic Name
OLOPATADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OLOPATADINE HYDROCHLORIDEActive
Quantity: 1.11 mg in 1 mL
Code: 2XG66W44KF
Classification: ACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT