Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021116
Company: ALVOGEN

Products on NDA 21116

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

Labels for NDA 021116

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021116s027lbl.pdf
04/23/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021116s017lbl.pdf
08/31/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021116s013lbl.pdf
03/10/2006	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021116s006lbl.pdf
10/24/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21116lbl.pdf