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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 202231

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NDA 202231 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Ani Pharms, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Onesource Specialty, Ph Health, Piramal Critical, Xiromed, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in twenty-one NDAs. It is available from thirty-eight suppliers. There are seven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEVOTHYROXINE SODIUM profile page.

The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 202231

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	levothyroxine sodium
Patents:	3

Pharmacology for NDA: 202231

Suppliers and Packaging for NDA: 202231

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	202231	NDA	ENDO USA, Inc.	42023-201	42023-201-01	1 VIAL, SINGLE-DOSE in 1 CARTON (42023-201-01) / 5 mL in 1 VIAL, SINGLE-DOSE
LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	202231	NDA	ENDO USA, Inc.	42023-202	42023-202-01	1 VIAL, SINGLE-DOSE in 1 CARTON (42023-202-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MCG/VIAL
Approval Date:	Jun 24, 2011	TE:	AP	RLD:	Yes
Patent:	9,006,289	Patent Expiration:	Oct 3, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,168,238	Patent Expiration:	Aug 29, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,168,239	Patent Expiration:	Aug 29, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

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