Search Orphan Drug Designations and Approvals
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Generic Name: | Somatropin for injection | ||||||||||||||||
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Trade Name: | Humatrope | ||||||||||||||||
Date Designated: | 06/12/1986 | ||||||||||||||||
Orphan Designation: | For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Somatropin for injection |
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Trade Name: | Humatrope | |
Marketing Approval Date: | 03/08/1987 | |
Approved Labeled Indication: | ||
Exclusivity End Date: | 03/08/1994 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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