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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021106
Company: PHARMACIA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOMAVERT PEGVISOMANT 10MG/VIAL INJECTABLE;SUBCUTANEOUS Prescription None No No
SOMAVERT PEGVISOMANT 15MG/VIAL INJECTABLE;SUBCUTANEOUS Prescription None No No
SOMAVERT PEGVISOMANT 20MG/VIAL INJECTABLE;SUBCUTANEOUS Prescription None No No
SOMAVERT PEGVISOMANT 25MG/VIAL INJECTABLE;SUBCUTANEOUS Prescription None No No
SOMAVERT PEGVISOMANT 30MG/VIAL INJECTABLE;SUBCUTANEOUS 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
03/25/2003 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21106_somavert_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21106ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021106_somavert.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2023 SUPPL-74 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021106s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021106Orig1s074ltr.pdf
08/20/2021 SUPPL-68 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021106Orig1s067,s068ltr.pdf
08/20/2021 SUPPL-67 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf
09/19/2019 SUPPL-64 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021106Orig1s064ltr.pdf
08/16/2019 SUPPL-55 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021106Orig1s055ltr.pdf
04/22/2016 SUPPL-50 Supplement

Label is not available on this site.
01/11/2016 SUPPL-48 Supplement

Label is not available on this site.
02/22/2016 SUPPL-46 Supplement

Label is not available on this site.
09/24/2019 SUPPL-45 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021106Orig1s045ltr.pdf
07/31/2014 SUPPL-44 Supplement

Label is not available on this site.
10/11/2013 SUPPL-43 Supplement

Label is not available on this site.
09/26/2013 SUPPL-42 Supplement

Label is not available on this site.
03/01/2013 SUPPL-39 Supplement

Label is not available on this site.
12/10/2013 SUPPL-36 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021106s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021106Orig1s036ltr.pdf
07/03/2012 SUPPL-31 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021106s031lbl.pdf
07/20/2010 SUPPL-28 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021106s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021106s028ltr.pdf
10/03/2008 SUPPL-16 Supplement

Label is not available on this site.
08/18/2008 SUPPL-15 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021106s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021106s015ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/27/2023 SUPPL-74 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021106s074lbl.pdf
08/20/2021 SUPPL-68 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf
08/20/2021 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf
08/20/2021 SUPPL-68 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf
08/20/2021 SUPPL-67 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf
08/20/2021 SUPPL-67 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf
08/20/2021 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021106s067s068lbl.pdf
09/19/2019 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s064lbl.pdf
08/16/2019 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021106s055lbl.pdf
12/10/2013 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021106s036lbl.pdf
07/03/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021106s031lbl.pdf
07/20/2010 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021106s028lbl.pdf
08/18/2008 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021106s015lbl.pdf
03/25/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21106_somavert_lbl.pdf
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