Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 206977
Company: INSTITUT BIOCHIMIQUE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIROSINT-SOL LEVOTHYROXINE SODIUM 13MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 25MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 50MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 75MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 88MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 100MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 112MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 125MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 137MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 150MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 175MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 200MCG/ML SOLUTION;ORAL 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
12/15/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206977s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206977Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206977Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2017 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206977s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206977Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/24/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206977s001lbl.pdf
12/15/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206977s000lbl.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