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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/25/1995 | 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 |
|---|---|---|---|---|---|
| 04/02/2024 | SUPPL-63 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019774s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019774Orig1s063ltr.pdf | |
| 03/13/2020 | SUPPL-53 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019774Orig1s053ltr.pdf |
| 07/19/2018 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf | |
| 07/19/2018 | SUPPL-50 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf | |
| 07/19/2018 | SUPPL-49 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf | |
| 07/19/2018 | SUPPL-48 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/180717s048s049s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s048,049,050,051Ltr.pdf | |
| 01/30/2018 | SUPPL-47 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf | |
| 01/30/2018 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf | |
| 01/30/2018 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019774s029s040s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf | |
| 12/13/2016 | SUPPL-38 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019774s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019774Orig1s038ltr.pdf | |
| 01/10/2017 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019774s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019774Orig1s037ltr.pdf | |
| 09/30/2016 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019774s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019774Orig1s036ltr.pdf | |
| 02/26/2016 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
| 07/30/2015 | SUPPL-32 | Supplement |
Label is not available on this site. |
||
| 06/12/2015 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019774Orig1s031ltr.pdf | |
| 08/06/2015 | SUPPL-30 | Supplement |
Label is not available on this site. |
||
| 01/30/2018 | SUPPL-29 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019774Orig1s029,019774Orig1s040,019774Orig1s045,019774Orig1s047ltr.pdf |
| 10/29/2014 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019774Orig1s028ltr.pdf | |
| 06/18/2014 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019774s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019774Orig1s027ltr.pdf | |
| 03/04/2015 | SUPPL-26 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019774s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019774Orig1s026ltr.pdf | |
| 07/19/2011 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019774s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019774s023ltr.pdf | |
| 04/12/2010 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019774s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019774s019ltr.pdf | |
| 06/25/2009 | SUPPL-16 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019774s016ltr.pdf |
| 02/15/2007 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019774s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019774s014ltr.pdf | |
| 03/16/2005 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19774s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19774s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019774_s009_TEV TROPIN.pdf | |
| 01/04/2002 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 04/09/2002 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 08/17/2000 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 02/03/2000 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 11/03/1999 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 09/09/1996 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-2 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/02/2024 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019774s063lbl.pdf | |
| 04/02/2024 | SUPPL-63 | Labeling-Package Insert | 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 |
BIO-TROPIN
There are no Therapeutic Equivalents.
ZOMACTON
There are no Therapeutic Equivalents.