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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/09/2025 | SUPPL-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020280s108lbl.pdf | |
| 08/16/2024 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020280s092lbl.pdf | |
| 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 |