Drugs@FDA: FDA-Approved Drugs
Company: GENENTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NUTROPIN | SOMATROPIN [rDNA origin] | N/A | Injectable; Injection | Prescription | 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 |
---|---|---|---|---|---|---|---|
03/09/1994 | ORIG-1 | Approval | N/A; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/13/2016 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019676Orig1s044,020168Orig1s024ltr.pdf | |
04/10/2012 | SUPPL-42 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019676s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf | |
02/15/2007 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019676s030, 020522s033ltr.pdf | |
02/23/2006 | SUPPL-26 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019676s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019676s026ltr.pdf | |
06/28/2005 | SUPPL-21 | Supplement |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf | |
06/28/2005 | SUPPL-20 | Supplement |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf | |
09/17/2001 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
05/02/2001 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
04/13/2000 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676S016_Nutropin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19676S16LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676s016_Nutropin.cfm | |
11/24/1999 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
11/03/1999 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
12/01/1999 | SUPPL-13 | Supplement |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin.cfm |
09/25/1998 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
09/25/1998 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
09/12/1997 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
12/15/1997 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
08/07/1996 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
08/21/1995 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
09/22/1995 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
08/25/1995 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
02/01/1996 | SUPPL-4 | Supplement |
Label is not available on this site. |
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02/03/1995 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
08/03/1994 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
07/21/1994 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/13/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf | |
04/10/2012 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019676s042lbl.pdf | |
02/15/2007 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf | |
02/23/2006 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019676s026lbl.pdf | |
06/28/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf | |
06/28/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf | |
06/28/2005 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf | |
06/28/2005 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf | |
04/13/2000 | SUPPL-16 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676S016_Nutropin_prntlbl.pdf |