ACZONE

207154 | Orange Book

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Filed Feb. 24, 2016
Type New Drug Application
Case Type New Drug Application
Ingredients DAPSONE
Dosage Form / Route TOPICAL and GEL
PatentExpiration
11,273,1328 years, 8 months from now
9,161,9268 years, 8 months from now
9,517,2198 years, 8 months from now
Last Updated: 2 years, 7 months ago
Date Patent / Filing No. Patent and Drug Application Information
11/18/20339517219Expiration of Patent No 9,517,219: (U-1033).
11/18/20339161926Expiration of Patent No 9,161,926: (drug product)
11/18/203311273132Expiration of Patent No 11,273,132: (drug product)
9/10/2019SUPPL-4Efficacy-New Patient Population, Labeling-Package Insert:
5/18/2018SUPPL-3Labeling-Package Insert:
2/24/2016
Approval for ACZONE, 7.5%
  • Reference Drug
  • Active Ingredient: DAPSONE
  • Dosage Form: GEL
  • Dosage Route: TOPICAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
2/24/2016ORIG-1Approval: