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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021112

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NDA 021112 describes TRI-LUMA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the TRI-LUMA profile page.

The generic ingredient in TRI-LUMA is fluocinolone acetonide; hydroquinone; tretinoin. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluocinolone acetonide; hydroquinone; tretinoin profile page.
Summary for 021112
Tradename:TRI-LUMA
Applicant:Galderma Labs Lp
Ingredient:fluocinolone acetonide; hydroquinone; tretinoin
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021112
Suppliers and Packaging for NDA: 021112
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112 NDA Galderma Laboratories, L.P. 0299-5950 N 0299-5950-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.01%;4%;0.05%
Approval Date:Jan 18, 2002TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 22, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 4, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 22, 2022Product Flag?YSubstance Flag?Delist Request?

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