Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019774
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
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
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.

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