Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215309

EQ 1.5% BASE
Marketing Status: Prescription
Proprietary Name: OPZELURA
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: EQ 1.5% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215309
Product Number: 001
Approval Date: Sep 21, 2021
Applicant Holder Full Name: INCYTE CORP
Marketing Status:  Prescription
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