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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021210
Company: STEVENS J
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UNITHROID LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
UNITHROID LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes Yes
UNITHROID LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB1,AB2,AB3 Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/10/2018 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021210s018lbl.pdf
02/08/2008 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021210s004lbl.pdf
02/08/2008 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021210s004lbl.pdf
08/21/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21210lbl.pdf
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