Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct Rx
Direct Rx
Direct Rx
079254320
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
72189-053Application Number
ANDA204812Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
October 23, 2019BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
OlopatadineActive
Code: 2XG66W44KFClass: ACTIMQuantity: 1 mg in 1 mL