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

Tradename:	TRI-LUMA
Applicant:	Galderma Labs Lp
Ingredient:	fluocinolone acetonide; hydroquinone; tretinoin
Patents:	0

Pharmacology for NDA: 021112

Mechanism of Action	Corticosteroid Hormone Receptor Agonists Melanin Synthesis Inhibitors
Physiological Effect	Depigmenting Activity

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:	RX	Dosage:	CREAM;TOPICAL			Strength	0.01%;4%;0.05%
Approval Date:	Jan 18, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021112

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

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