Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021426
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OMNITROPE | SOMATROPIN | 5.8MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
OMNITROPE | SOMATROPIN | 1.5MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
OMNITROPE | SOMATROPIN | 5MG/1.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
OMNITROPE | SOMATROPIN | 10MG/1.5ML | 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 |
---|---|---|---|---|---|---|---|
05/30/2006 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021426s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021426s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/25/2022 | SUPPL-50 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021426Orig1s050ltr.pdf |
12/13/2016 | SUPPL-34 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021426Orig1s034ltr.pdf | |
07/14/2014 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
08/29/2014 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021426Orig1s028ltr.pdf | |
08/22/2013 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
06/18/2013 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
04/04/2013 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
02/15/2017 | SUPPL-22 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021426s022lbl.pdf | |
04/13/2011 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s018ltr.pdf | |
07/22/2011 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s017ltr.pdf | |
08/26/2010 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s015ltr.pdf | |
04/23/2010 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s008.pdf | |
04/23/2010 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s007.pdf | |
03/25/2009 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021426s006ltr.pdf | |
08/25/2008 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s004.pdf | |
01/16/2008 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s002.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2017 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021426s022lbl.pdf | |
12/13/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf | |
12/13/2016 | SUPPL-34 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf | |
08/29/2014 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf | |
07/22/2011 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf | |
04/13/2011 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf | |
08/26/2010 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf | |
04/23/2010 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf | |
04/23/2010 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf | |
03/25/2009 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf | |
03/25/2009 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf | |
08/25/2008 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf | |
08/25/2008 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf | |
01/16/2008 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf | |
01/16/2008 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf | |
05/30/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf |
OMNITROPE
There are no Therapeutic Equivalents.