Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 020522
Company: GENENTECH
Company: GENENTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUTROPIN AQ | SOMATROPIN | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NUTROPIN AQ NUSPIN | SOMATROPIN | 5MG/2ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| NUTROPIN AQ NUSPIN | SOMATROPIN | 20MG/2ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| NUTROPIN AQ NUSPIN | SOMATROPIN | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| NUTROPIN AQ PEN | SOMATROPIN | 10MG/2ML (5MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NUTROPIN AQ PEN | SOMATROPIN | 20MG/2ML (10MG/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1995 | 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-61 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020522s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020522Orig1s061ltr.pdf | |
| 11/30/2016 | SUPPL-60 | Supplement |
Label is not available on this site. |
||
| 05/18/2016 | SUPPL-59 | Supplement |
Label is not available on this site. |
||
| 03/17/2016 | SUPPL-58 | Supplement |
Label is not available on this site. |
||
| 02/26/2016 | SUPPL-57 | Supplement |
Label is not available on this site. |
||
| 01/13/2016 | SUPPL-56 | Supplement |
Label is not available on this site. |
||
| 06/23/2015 | SUPPL-55 | Supplement |
Label is not available on this site. |
||
| 05/26/2015 | SUPPL-54 | Supplement |
Label is not available on this site. |
||
| 05/15/2014 | SUPPL-52 | Supplement |
Label is not available on this site. |
||
| 06/18/2014 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020522Orig1s051ltr.pdf | |
| 09/17/2013 | SUPPL-50 | Supplement |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-49 | Supplement |
Label is not available on this site. |
||
| 04/10/2012 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020522s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf | |
| 01/03/2008 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf | |
| 01/03/2008 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf | |
| 02/15/2007 | SUPPL-33 | 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 | |
| 11/18/2005 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s027ltr.pdf | |
| 01/03/2008 | SUPPL-26 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf | |
| 06/28/2005 | SUPPL-22 | Supplement |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf | |
| 06/28/2005 | SUPPL-21 | Supplement |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf | |
| 04/22/2002 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20522s17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20522s017.pdf | |
| 09/17/2001 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 05/02/2001 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 04/13/2000 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20522S13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522s013_Somatropin.cfm | |
| 10/13/1999 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-11 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020522_S011_NUTROPIN FOR INJ.pdf |
| 11/03/1999 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 12/01/1999 | SUPPL-9 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20522S9LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20522S9.PDF |
| 09/25/1998 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 10/26/1998 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 07/09/1998 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-4 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522a_s004.pdf |
| 09/12/1997 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 03/24/1997 | SUPPL-2 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522_s002ap.pdf |
| 08/07/1996 | 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-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020522s061lbl.pdf | |
| 06/18/2014 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf | |
| 04/10/2012 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020522s045lbl.pdf | |
| 01/03/2008 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf | |
| 01/03/2008 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf | |
| 01/03/2008 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf | |
| 01/03/2008 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf | |
| 01/03/2008 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf |
| 02/15/2007 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf | |
| 11/18/2005 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s027lbl.pdf | |
| 06/28/2005 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf | |
| 06/28/2005 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf | |
| 06/28/2005 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf | |
| 06/28/2005 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf | |
| 04/22/2002 | SUPPL-17 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20522s17lbl.pdf | |
| 04/13/2000 | SUPPL-13 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf |