Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207154

Marketing Status: Prescription
Active Ingredient: DAPSONE
Proprietary Name: ACZONE
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 7.5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N207154
Product Number: 001
Approval Date: Feb 24, 2016
Applicant Holder Full Name: ALMIRALL LLC
Marketing Status:  Prescription
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