Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 020280
Company: PHARMACIA
Company: PHARMACIA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENOTROPIN | SOMATROPIN | 5.8MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN | SOMATROPIN | 13.8MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 0.2MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 0.4MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 0.6MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 1.5MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 0.8MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 1MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 1.2MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 1.4MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 1.6MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 1.8MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| GENOTROPIN PRESERVATIVE FREE | SOMATROPIN | 2MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/24/1995 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/2020 | SUPPL-90 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020280Orig1s090ltr.pdf | |
| 12/13/2016 | SUPPL-88 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s088ltr.pdf | |
| 01/27/2017 | SUPPL-87 | Supplement |
Label is not available on this site. |
||
| 06/16/2016 | SUPPL-84 | Supplement |
Label is not available on this site. |
||
| 12/28/2015 | SUPPL-82 | Supplement |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-81 | Supplement |
Label is not available on this site. |
||
| 02/16/2015 | SUPPL-80 | Supplement |
Label is not available on this site. |
||
| 09/06/2016 | SUPPL-79 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s079ltr.pdf | |
| 06/22/2015 | SUPPL-78 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020280s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020280Orig1s078ltr.pdf | |
| 09/25/2014 | SUPPL-77 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020280Orig1s077ltr.pdf | |
| 10/17/2013 | SUPPL-75 | Supplement |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-74 | Supplement |
Label is not available on this site. |
||
| 02/06/2012 | SUPPL-72 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020280s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020280s072ltr.pdf | |
| 05/17/2011 | SUPPL-71 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020280s071ltr.pdf | |
| 02/02/2010 | SUPPL-68 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020280s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020280s068ltr.pdf | |
| 12/15/2008 | SUPPL-66 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s066ltr.pdf | |
| 05/20/2009 | SUPPL-64 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s064ltr.pdf | |
| 01/05/2009 | SUPPL-61 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s061ltr.pdf | |
| 06/12/2008 | SUPPL-60 | Supplement |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020280se1-060_SUMR.pdf | |
| 03/14/2007 | SUPPL-57 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s057ltr.pdf | |
| 07/22/2007 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s055ltr.pdf | |
| 04/27/2006 | SUPPL-49 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020280s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020280s049LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020280_s049_genotropin_medr.pdf | |
| 10/31/2003 | SUPPL-44 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280slr044ltr.pdf |
| 11/05/2002 | SUPPL-41 | Supplement |
Label is not available on this site. |
||
| 05/12/2003 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scs040ltr.pdf | |
| 08/15/2002 | SUPPL-39 | Supplement |
Label is not available on this site. |
||
| 03/28/2003 | SUPPL-38 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scm038ltr.pdf |
| 01/29/2002 | SUPPL-37 | Supplement |
Label is not available on this site. |
||
| 09/21/2001 | SUPPL-36 | Supplement |
Label is not available on this site. |
||
| 07/09/2001 | SUPPL-35 | Supplement |
Label is not available on this site. |
||
| 01/26/2001 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
| 12/08/2000 | SUPPL-33 | Supplement |
Label is not available on this site. |
||
| 11/07/2000 | SUPPL-32 | Supplement |
Label is not available on this site. |
||
| 07/25/2001 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20280s31lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20280s31ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-280S031_Genotropin.cfm | |
| 07/21/2000 | SUPPL-30 | Supplement |
Label is not available on this site. |
||
| 10/05/2000 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 08/18/2000 | SUPPL-28 | Supplement |
Label is not available on this site. |
||
| 07/31/2000 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
| 05/26/2000 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 06/20/2000 | SUPPL-23 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF |
| 04/11/2000 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 01/19/2000 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 04/27/1999 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 02/24/1999 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 07/30/1998 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 08/18/1998 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 01/05/1998 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 01/27/1998 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 10/31/1997 | SUPPL-8 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020280s008.pdf |
| 10/23/1996 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 11/19/1996 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 07/15/1996 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 05/24/1996 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 04/19/1996 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 04/24/1996 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 12/20/1995 | 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 |
|---|---|---|---|---|---|
| 01/08/2020 | SUPPL-90 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF | |
| 12/13/2016 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s088lbl.pdf | |
| 09/06/2016 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s079lbl.pdf | |
| 06/22/2015 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020280s078lbl.pdf | |
| 09/25/2014 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf | |
| 02/06/2012 | SUPPL-72 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020280s072lbl.pdf | |
| 05/17/2011 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf | |
| 02/02/2010 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020280s068lbl.pdf | |
| 05/20/2009 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf | |
| 05/20/2009 | SUPPL-64 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf | |
| 01/05/2009 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s061lbl.pdf | |
| 12/15/2008 | SUPPL-66 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s066lbl.pdf | |
| 06/12/2008 | SUPPL-60 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s060lbl.pdf | |
| 07/22/2007 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf | |
| 03/14/2007 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s057lbl.pdf | |
| 04/27/2006 | SUPPL-49 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020280s049lbl.pdf | |
| 05/12/2003 | SUPPL-40 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf |
| 07/25/2001 | SUPPL-31 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20280s31lbl.pdf |
GENOTROPIN
There are no Therapeutic Equivalents.
GENOTROPIN PRESERVATIVE FREE
There are no Therapeutic Equivalents.