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Details for New Drug Application (NDA): 020474

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NDA 020474 describes VEXOL, which is a drug marketed by Alcon and is included in one NDA. It is available from one supplier. Additional details are available on the VEXOL profile page.

The generic ingredient in VEXOL is rimexolone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the rimexolone profile page.

Summary for NDA: 020474

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 020474

Suppliers and Packaging for NDA: 020474

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION/DROPS;OPHTHALMIC 020474 NDA Alcon Laboratories, Inc 0065-0627 0065-0627-03 10 mL in 1 BOTTLE, PLASTIC (0065-0627-03)
SUSPENSION/DROPS;OPHTHALMIC 020474 NDA Alcon Laboratories, Inc 0065-0627 0065-0627-07 5 mL in 1 BOTTLE, PLASTIC (0065-0627-07)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION/DROPS;OPHTHALMICStrength1%
Approval Date:Dec 30, 1994TE:RLD:No

Expired Orange Book Patents for NDA: 020474

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
SUSPENSION/DROPS;OPHTHALMIC020474-001Dec 30, 19944,686,214<disabled>
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