Search Orphan Drug Designations and Approvals
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Generic Name: | 17-a-hydroxyprogesterone caporate (oral formulation) |
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Date Designated: | 06/01/2015 |
Orphan Designation: | Prevention of preterm birth in women with a singleton pregnancy |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Lipocine, Inc. 675 Arapeen Drive Suite 202 Salt Lake City, Utah 84108 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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