Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Alembic Pharmaceuticals Inc.
918601238
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
62332-501Application Number
ANDA209919Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
November 11, 2016SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
OlopatadineActive
Code: 2XG66W44KFClass: ACTIMQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT