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Generated: November 18, 2018

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Details for New Drug Application (NDA): 021737

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NDA 021737 describes RETISERT, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the RETISERT profile page.

The generic ingredient in RETISERT is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 021737
Tradename:RETISERT
Applicant:Bausch And Lomb
Ingredient:fluocinolone acetonide
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021737
Medical Subject Heading (MeSH) Categories for 021737
Suppliers and Packaging for NDA: 021737
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737 NDA Bausch & Lomb Incorporated 24208-416 24208-416-01 1 POUCH in 1 CARTON (24208-416-01) > 1 IMPLANT in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;INTRAVITREALStrength0.59MG
Approval Date:Apr 8, 2005TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 22, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
Patent:➤ Sign UpPatent Expiration:Mar 22, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE

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