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NDA[removed]S-001 Page 3 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LASTACAFT® safely and effectively. See full
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Document Date: 2014-12-05 11:06:38

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City

Irvine / Rochester / Reference / /

Company

Par Sterile Products LLC / Allergan Inc. / Ames / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

ophthalmic solution / alcaftadine ophthalmic solution / drug product / topical ophthalmic medicinal product / /

MedicalCondition

mouse lymphoma assay / disease / headache / nasopharyngitis / Sterility / Carcinogenesis / ocular itching / erythema / itching / eye irritation / allergic conjunctivitis / eye pruritus / CONTRAINDICATIONS Hypersensitivity / Eye Injury / Hypersensitivity / irritation / /

Organization

DOSAGE AND ADMINISTRATION / FDA / /

/

Position

Major / /

Product

edetate disodium / sodium chloride / S-001 / /

ProvinceOrState

California / Michigan / /

Technology

Pharmacokinetics / /

URL

www.fda.gov/medwatch / www.allergan.com/products/patent_notices / /

SocialTag