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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-68 Labeling-Container/Carton Labels 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
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-Container/Carton Labels 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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