Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 211172
Company: AKCEA THERAPS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEGSEDI INOTERSEN SODIUM EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/05/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211172Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211172Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2019 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211172s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211172Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211172s004lbl.pdf
10/05/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English