Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 019774
Company: FERRING
Company: FERRING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIO-TROPIN | SOMATROPIN | 4.8MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ZOMACTON | SOMATROPIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| ZOMACTON | SOMATROPIN | 10MG/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-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019774s065lbl.pdf | |
| 04/02/2024 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019774s063lbl.pdf | |
| 04/02/2024 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019774s063lbl.pdf | |
| 07/19/2018 | SUPPL-51 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf | |
| 07/19/2018 | SUPPL-50 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf | |
| 07/19/2018 | SUPPL-49 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf | |
| 07/19/2018 | SUPPL-48 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf | |
| 01/30/2018 | SUPPL-47 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf | |
| 01/30/2018 | SUPPL-47 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf | |
| 01/30/2018 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf | |
| 01/30/2018 | SUPPL-45 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf | |
| 01/30/2018 | SUPPL-40 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf | |
| 01/10/2017 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019774s037lbl.pdf | |
| 12/13/2016 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019774s038lbl.pdf | |
| 09/30/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019774s036lbl.pdf | |
| 06/12/2015 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s031lbl.pdf | |
| 03/04/2015 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s026lbl.pdf | |
| 10/29/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s028lbl.pdf | |
| 06/18/2014 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s027lbl.pdf | |
| 07/19/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019774s023lbl.pdf | |
| 04/12/2010 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019774s019lbl.pdf | |
| 02/15/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019774s014lbl.pdf | |
| 03/16/2005 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19774s009lbl.pdf |