Olopatadine Hydrochloride

Product NDC

68083-230

11-digit product format

680830230

Labeler code

68083

Product ID

68083-230_2515239c-e23c-4d40-88ce-49ffae0524f4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

olopatadine hydrochloride ophthalmic solution USP, 0.1%

Dosage form

SOLUTION/ DROPS

Route

OPHTHALMIC

Labeler

Gland Pharma Limited

Application

ANDA209619

Marketing category

ANDA

Marketing start

2017-02-14

Marketing end

0000-00-00

Substance

OLOPATADINE HYDROCHLORIDE

Active strength

1 mg/mL

Pharmacologic classes

Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record