Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021924
Company: INSTITUT BIOCHIMIQUE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIROSINT LEVOTHYROXINE SODIUM 0.025MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.05MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.075MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.1MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.125MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.15MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.112MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.137MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.088MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.175MG CAPSULE;ORAL Prescription None Yes No
TIROSINT LEVOTHYROXINE SODIUM 0.200MG CAPSULE;ORAL Prescription None Yes Yes
TIROSINT LEVOTHYROXINE SODIUM 0.013MG CAPSULE;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
10/13/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021924lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021924s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021924s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2017 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021924s013lbl.pdf
04/25/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/11/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/04/2012 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021924s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021924s006ltr.pdf
12/17/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021924s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021924s002ltr.pdf
01/01/2008 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2017 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021924s013lbl.pdf
03/04/2012 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021924s006lbl.pdf
12/17/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021924s002lbl.pdf
10/13/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021924lbl.pdf

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