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Generated: November 18, 2018

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Details for New Drug Application (NDA): 018771

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NDA 018771 describes LACRISERT, which is a drug marketed by Aton and is included in one NDA. It is available from one supplier. Additional details are available on the LACRISERT profile page.

The generic ingredient in LACRISERT is hydroxypropyl cellulose. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydroxypropyl cellulose profile page.
Summary for 018771
Tradename:LACRISERT
Applicant:Aton
Ingredient:hydroxypropyl cellulose
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018771
Mechanism of ActionDemulcent Activity
Suppliers and Packaging for NDA: 018771
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACRISERT hydroxypropyl cellulose INSERT;OPHTHALMIC 018771 NDA Bausch & Lomb Incorporated 24208-800 24208-800-10 10 BLISTER PACK in 1 CARTON (24208-800-10) > 1 PELLET in 1 BLISTER PACK
LACRISERT hydroxypropyl cellulose INSERT;OPHTHALMIC 018771 NDA Bausch & Lomb Incorporated 24208-800 24208-800-60 60 BLISTER PACK in 1 CARTON (24208-800-60) > 1 PELLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INSERT;OPHTHALMICStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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