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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206977
Company: IBSA

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
TIROSINT-SOL LEVOTHYROXINE SODIUM 37.5MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 44MCG/ML SOLUTION;ORAL Prescription None Yes No
TIROSINT-SOL LEVOTHYROXINE SODIUM 62.5MCG/ML SOLUTION;ORAL Prescription None Yes 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
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
11/16/2023 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206977s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206977Orig1s010, s012ltr.pdf
11/16/2023 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206977s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206977Orig1s010, s012ltr.pdf
01/13/2021 SUPPL-9 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206977Orig1s009Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206977Orig1s009Corrected_ltr.pdf
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
11/16/2023 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206977s010s012lbl.pdf
11/16/2023 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206977s010s012lbl.pdf
01/13/2021 SUPPL-9 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206977Orig1s009Corrected_lbl.pdf
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
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