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

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

azelastine-ctn.jpg

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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

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