Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 BX Yes Yes
ZOMACTON SOMATROPIN 10MG/VIAL INJECTABLE;INJECTION Prescription None Yes 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 Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
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)
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 Efficacy-New Indication 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 Efficacy-New Indication 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 Efficacy-New Indication 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 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert 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 Efficacy-New Dosing Regimen 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 Efficacy-New Indication 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 Labeling-Package Insert 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 Labeling-Container/Carton Labels 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 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

07/30/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/12/2015 SUPPL-31 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

01/30/2018 SUPPL-29 Labeling-Package Insert 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
10/29/2014 SUPPL-28 Labeling-Package Insert 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 Labeling-Package Insert 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 Labeling-Container/Carton Labels 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 Labeling-Package Insert 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 Labeling-Package Insert 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 Labeling-Container/Carton Labels, Labeling-Package Insert 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 Labeling 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 Labeling 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 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/2000 SUPPL-6 Labeling

Label is not available on this site.

02/03/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/03/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1996 SUPPL-2 Manufacturing (CMC)-Control

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
01/30/2018 SUPPL-29 Labeling-Package Insert 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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