Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202799
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMONTYS PEGINESATIDE ACETATE EQ 10MG BASE/ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
OMONTYS PEGINESATIDE ACETATE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
OMONTYS PRESERVATIVE FREE PEGINESATIDE ACETATE EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
OMONTYS PRESERVATIVE FREE PEGINESATIDE ACETATE EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
OMONTYS PRESERVATIVE FREE PEGINESATIDE ACETATE EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
OMONTYS PRESERVATIVE FREE PEGINESATIDE ACETATE EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
OMONTYS PRESERVATIVE FREE PEGINESATIDE ACETATE EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued None No No
OMONTYS PRESERVATIVE FREE PEGINESATIDE ACETATE EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) SOLUTION;INTRAVENOUS, SUBCUTANEOUS Discontinued 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
03/27/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202799_Omontys_Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2012 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2012 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf
12/04/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf
03/27/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s000lbl.pdf

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