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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209354

DUOBRII (HALOBETASOL PROPIONATE; TAZAROTENE)
0.01%;0.045%
Marketing Status: Prescription
Active Ingredient: HALOBETASOL PROPIONATE; TAZAROTENE
Proprietary Name: DUOBRII
Dosage Form; Route of Administration: LOTION; TOPICAL
Strength: 0.01%;0.045%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209354
Product Number: 001
Approval Date: Apr 25, 2019
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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