OLOPATADINE HYDROCHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 147681894

Effective Date

August 29, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Olopatadine(1.11 mg in 1 mL)

Manufacturing Establishments1

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

Labeler

H.J. Harkins Company, Inc.

DUNS Number

147681894

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

NDC Product Code

76519-1161

Application Number

ANDA206306

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

August 29, 2019

Ingredients

Code: 2XG66W44KFClass: ACTIMQuantity: 1.11 mg in 1 mL