Details for New Drug Application (NDA): 021112
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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
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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