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Last Updated: November 21, 2024

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. 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
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 0299-5950-02 1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE
TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112 NDA Galderma Laboratories, L.P. 0299-5950 0299-5950-30 1 TUBE in 1 CARTON (0299-5950-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.01%;4%;0.05%
Approval Date:Jan 18, 2002TE:RLD:Yes

Expired US Patents for NDA 021112

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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