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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021924
Company: IBSA

Products on NDA 021924

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIROSINT	LEVOTHYROXINE SODIUM	0.025MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.05MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.1MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.125MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE;ORAL	Prescription	AB	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.088MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE;ORAL	Prescription	AB	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
TIROSINT	LEVOTHYROXINE SODIUM	0.013MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.0375MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.044MG	CAPSULE;ORAL	Prescription	None	Yes	No
TIROSINT	LEVOTHYROXINE SODIUM	0.0625MG	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021924

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021924lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021924s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021924s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2022	SUPPL-21	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021924Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021924Orig1s021ltr.pdf
12/08/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021924s013lbl.pdf
04/25/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/11/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/04/2012	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021924s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021924s006ltr.pdf
12/17/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021924s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021924s002ltr.pdf
01/01/2008	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 021924

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2022	SUPPL-21	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021924Orig1s021lbl.pdf
12/08/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021924s013lbl.pdf
03/04/2012	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021924s006lbl.pdf
12/17/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021924s002lbl.pdf
10/13/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021924lbl.pdf

Therapeutic Equivalents for NDA 021924

TIROSINT

CAPSULE;ORAL; 0.137MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIROSINT	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE;ORAL	Prescription	Yes	AB	021924	IBSA

CAPSULE;ORAL; 0.175MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIROSINT	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE;ORAL	Prescription	Yes	AB	021924	IBSA

CAPSULE;ORAL; 0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIROSINT	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE;ORAL	Prescription	Yes	AB	021924	IBSA

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