LUTATHERA

208700 | Orange Book

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Filed Jan. 26, 2018
Type New Drug Application
Case Type New Drug Application
Ingredients LUTETIUM LU 177 DOTATATE
Dosage Form / Route SOLUTION and INTRAVENOUS
PatentExpiration
10,596,27613 years, 3 months from now
10,596,27813 years, 3 months from now
Last Updated: 2 years, 8 months ago
Date Patent / Filing No. Patent and Drug Application Information
7/25/203810596278Expiration of Patent No 10,596,278: (drug product)
7/25/203810596276Expiration of Patent No 10,596,276: (drug product)
6/13/2022SUPPL-23Labeling-Package Insert:
6/13/2022SUPPL-19Efficacy-Labeling Change With Clinical Data:
6/6/2022SUPPL-20Labeling-Container/Carton Labels: Label is not available on this site.
5/29/2020SUPPL-1:
5/28/2020SUPPL-10Efficacy-Labeling Change With Clinical Data: Label is not available on this site.
1/26/2018
Approval for LUTATHERA, 10mCi/ML
  • Reference Drug
  • Active Ingredient: LUTETIUM LU 177 DOTATATE
  • Dosage Form: SOLUTION
  • Dosage Route: INTRAVENOUS
  • Therapeutic Equivalence:
1/26/2018ORIG-1Approval: