Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Akorn Operating Company LLC
117693100
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Akorn
Akorn
Akorn Operating Company LLC
117696873
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
50383-943Application Number
ANDA213757Marketing Category
ANDA (C73584)Route of Administration
NASALEffective Date
January 11, 2023OlopatadineActive
Code: 2XG66W44KFClass: ACTIMQuantity: 665 ug in 1 1
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT