Azelastine Hydrochloride (Page 2 of 2)

DOSAGE AND ADMINISTRATION

The recommended dose is one drop instilled into each affected eye twice a day.

HOW SUPPLIED

Azelastine hydrochloride ophthalmic
solution, 0.05% is supplied as follows: 6 mL (NDC 72266-141-01) solution in a 10 mL LDPE container with a LDPE dropper tip and a white
HDPE screw cap.

Storage
Store UPRIGHT between 2° and 25°C (36° and 77°F).

Rx Only

Distributed by:
Fosun Pharma USA Inc.
Princeton, NJ 08540
Made in India.

November 2019

LEA-020311-

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label:
6 mL
Azelastine Hydrochloride Ophthalmic Solution
0.05%
For use in the eyes only
Rx only azelastine-lbl.jpg

Carton Label: 6 mL
Azelastine Hydrochloride Ophthalmic Solution
0.05% For use in the eyes only Rx only

azelastine-ctn.jpg

AZELASTINE HYDROCHLORIDE azelastine hydrochloride solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72266-141 Route of Administration INTRAOCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELASTINE HYDROCHLORIDE (AZELASTINE) AZELASTINE HYDROCHLORIDE 0.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE 0.125 mg in 1 mL EDETATE DISODIUM HYPROMELLOSES SORBITOL SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72266-141-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 6 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (72266-141-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210092 09/08/2020

Labeler — Fosun Pharma USA Inc (080920998)

Revised: 09/2020 Fosun Pharma USA Inc