Azelastine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Azelastine Hydrochloride

Sun Pharma Global FZE

Azelastine Hydrochloride Ophthalmic Solution, 0.05%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

AZELASTINE HYDROCHLORIDE DESCRIPTION


1
Azelastine Hydrochloride
22243

Active:Preservative:Inactives:

CLINICAL PHARMACOLOGY


1

Pharmacokinetics and Metabolism




Clinical Trials




AZELASTINE HYDROCHLORIDE INDICATIONS AND USAGE


AZELASTINE HYDROCHLORIDE CONTRAINDICATIONS


WARNINGS


PRECAUTIONS

Information for Patients




whose eyes are not red

Carcinogenesis, Mutagenesis, Impairment of Fertility


µ

Pregnancy


th

Nursing Mothers


Pediatric Use


Geriatric Use


AZELASTINE HYDROCHLORIDE ADVERSE REACTIONS




AZELASTINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION


HOW SUPPLIED


Storage




Sun Pharmaceutical Ind. Ltd.




Caraco Pharmaceutical Laboratories, Ltd.



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL


NDC 47335-938-90
Azelastine Hydrochloride Ophthalmic Solution, 0.05%
6 mL - Sterile
For the Eye Only
Rx only
Azelastine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON


NDC 47335-938-90
Azelastine Hydrochloride Ophthalmic Solution, 0.05%
6 mL - Sterile
For the Eye Only
Rx only
SUN PHARMACEUTICAL INDUSTRIES LTD.
Azelastine Hydrochloride

Azelastine Hydrochloride

Azelastine Hydrochloride SOLUTION/ DROPS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-938
Route of Administration INTRAOCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AZELASTINE HYDROCHLORIDE AZELASTINE 0.5 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
EDETATE DISODIUM
hypromellose
sorbitol
SODIUM HYDROXIDE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BOTTLE, PLASTIC
2 NDC:47335-938-90 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078738 2010-05-31


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