Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021301
Company: KING PHARMS

Products on NDA 21301

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOXYL	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	No
LEVOXYL	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription	AB1,AB3	Yes	Yes
LEVOXYL	LEVOTHYROXINE SODIUM	0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 021301

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2018	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021301s038lbl.pdf
03/21/2011	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf
03/21/2011	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf
07/08/2008	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021301s026lbl.pdf
03/08/2005	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21301s014lbl.pdf
05/25/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21301lbl.pdf