Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021137
Company: GENUS LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOLET LEVOTHYROXINE SODIUM 0.025MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.05MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.075MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.088MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.1MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.112MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.125MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.137MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.15MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.175MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.2MG TABLET;ORAL Discontinued None No No
LEVOLET LEVOTHYROXINE SODIUM 0.3MG TABLET;ORAL 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
06/06/2003 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-137_Levolet_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21137ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-137_Levolet.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-137_Levolet_Prntlbl.pdf

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