Search Orphan Drug Designations and Approvals
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Generic Name: | Somatropin for injection | ||||||||||||||||
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Trade Name: | Nutropin | ||||||||||||||||
Date Designated: | 08/04/1989 | ||||||||||||||||
Orphan Designation: | Treatment of growth retardation associated with chronic renal failure. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Genentech, Inc. 460 Point San Bruno Boulevard South San Francisco, California 94080 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: | Nutropin | |
Marketing Approval Date: | 11/17/1993 | |
Approved Labeled Indication: | Treatment of children with growth failure associated with chronic renal insufficency. | |
Exclusivity End Date: | 11/17/2000 | |
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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