OLOPATADINE HYDROCHLORIDE

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Alembic Pharmaceuticals Inc.

DUNS Number

918601238

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

62332-502

Application Number

ANDA209420

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

April 29, 2019

Ingredients

Code: 2XG66W44KFClass: ACTIMQuantity: 2 mg in 1 mL

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT