Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021210
Company: STEVENS J

• Other Important Information from FDA

Products on NDA 21210

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

Labels for NDA 021210

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