EPINASTINE HYDROCHLORIDE description, usages, side effects, indications, overdosage, supplying and lots more!

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EPINASTINE HYDROCHLORIDE

Sun Pharmaceutical Industries Limited

Epinastine Hydrochloride Ophthalmic Solution 0.05%Sterile


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

EPINASTINE HYDROCHLORIDE DESCRIPTION





EPINASTINE HYDROCHLORIDE
Chemical Name:
 
Each mL contains: ActivePreservative: Inactives:

CLINICAL PHARMACOLOGY


112122


 
Clinical studies:

EPINASTINE HYDROCHLORIDE INDICATIONS AND USAGE


EPINASTINE HYDROCHLORIDE CONTRAINDICATIONS


WARNINGS


PRECAUTIONS

Information for Patients:






Carcinogenesis, Mutagenesis, Impairment of Fertility:


Salmonella in vitro in vitro in vivo in vivo/in vitro

Pregnancy:


Teratogenic Effects: Pregnancy Category C





Nursing Mothers:


Pediatric Use:


Geriatric Use:


EPINASTINE HYDROCHLORIDE ADVERSE REACTIONS






EPINASTINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION




HOW SUPPLIED





 
Storage:



 

Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON


NDC 62756-329-90
Epinastine HCl Ophthalmic Solution
0.05%
FOR USE IN THE EYES ONLY
Rx only
5 mL
SUN PHARMACEUTICAL INDUSTRIES LTD.
EPINASTINE HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-329
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
EPINASTINE HYDROCHLORIDE EPINASTINE 0.5 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
EDETATE DISODIUM
SODIUM CHLORIDE
sodium phosphate, monobasic, dihydrate
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE
2 NDC:62756-329-90 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091626 2011-11-01


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