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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Ritonavir powder for oral suspension
Trade Name: Norvir Powder for Oral Suspension
Date Designated: 01/11/2017
Orphan Designation: Use with other antiretroviral agents for the treatment of pediatric HIV-1 infection
Orphan Designation Status: Designated/Approved/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 04/03/2020
AbbVie Inc.
Regulatory Affairs
1 Waukegan Road
North Chicago, Illinois 60044
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
1 Generic Name: Ritonavir powder for oral suspension
Trade Name: Norvir Powder for Oral Suspension
Marketing Approval Date: 06/07/2017
Approved Labeled Indication: Used in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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