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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021137
Company: GENUS LIFESCIENCES

Products on NDA 21137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOLET	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No
LEVOLET	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB2,AB3,AB4	No	No

Labels for NDA 021137

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2021	SUPPL-4	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021137s002s003s004lbl.pdf
12/17/2021	SUPPL-3	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021137s002s003s004lbl.pdf
12/17/2021	SUPPL-2	Efficacy-Accelerated Approval Confirmatory Study	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021137s002s003s004lbl.pdf
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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