Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Sandoz Inc
005387188
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Kyowa Pharma Chemical Co., Ltd.
Sandoz Inc
Sandoz Inc
690852371
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
61314-320Application Number
NDA021861Marketing Category
NDA authorized generic (C73605)Route of Administration
NASALEffective Date
May 23, 2016BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
OlopatadineActive
Code: 2XG66W44KFClass: ACTIMQuantity: 665 ug in 100 uL