Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021106
Company: PHARMACIA
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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