Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202799
Company: TAKEDA PHARMS USA
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 |