Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021112

TRI-LUMA (FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN)
0.01%;4%;0.05% Marketing Status: Prescription

Active Ingredient: FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Proprietary Name: TRI-LUMA
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.01%;4%;0.05%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021112
Product Number: 001
Approval Date: Jan 18, 2002
Applicant Holder Full Name: GALDERMA LABORATORIES LP
Marketing Status:  Prescription
Patent and Exclusivity Information

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