Last Updated: November 8, 2026

Details for New Drug Application (NDA): 210831

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NDA 210831 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, Alembic, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in twenty-two NDAs. It is available from thirty-eight suppliers. There are eight 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 is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 210831

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Amneal
Ingredient:	levothyroxine sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.025MG
Approval Date:	Feb 19, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.05MG
Approval Date:	Feb 19, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.075MG
Approval Date:	Feb 19, 2019	TE:		RLD:	No

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