Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021075
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTROPIN DEPOT SOMATROPIN RECOMBINANT 13.5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
NUTROPIN DEPOT SOMATROPIN RECOMBINANT 18MG/VIAL INJECTABLE;INJECTION Discontinued None No No
NUTROPIN DEPOT SOMATROPIN RECOMBINANT 22.5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/22/1999 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21075ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21075_Nutropin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/20/2004 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21075s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21075s008ltr.pdf
12/07/2007 SUPPL-7 Labeling

Label is not available on this site.

05/02/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/20/2004 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21075s008lbl.pdf
12/22/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21075lbl.pdf

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