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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tadalafil
Date Designated: 03/23/2026
Orphan Designation: treatment of idiopathic pulmonary fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shenzhen Hanhui Pharmaceutical Technology Co., Ltd
Room 201, Building 2, Huahan Technology Industrial Park
No. 19 Qiyun West Road, Pingshan District
Shenzhen, Guangdong 518000
China

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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