Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RPK Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
147096275
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OLOPATADINE HYDROCHLORIDE
Product Details
NDC Product Code
53002-0510Application Number
ANDA206306Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
April 26, 2023SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
OlopatadineActive
Code: 2XG66W44KFClass: ACTIMQuantity: 1.11 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT